Protak Scientific in China
Protak Scientific China recently Exhibited at the SinoPhex Conference. Our technical and sales team in China is already onboarding new customers to the Enzyme Indicators technology.
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Join our Network of Distributors & Sales Agents
Join our rapidly growing network of Distributors and Sales Agents across the globe. We are looking for organisations who work within the pharmaceutical sector and are familiar with Hydrogen Peroxide Decontamination processes. Alternatively if you have products and services in and around Quality Assurance and Validation contact us for more information on partnering with Protak…
Join our Protak Webinar Series
We are proud to announce our Webinar Series is now ‘live’. Register your place for a front row seat. We will be presenting our in house experts as well as Industry Experts over the forthcoming weeks. Learn all you need to know about how our Enzyme Indicators can improve your processes and add value. To…
COVID-19 Company Update
Dear Customers and Partners, We hope that you and your loved ones are healthy and safe in this challenging time of Covid_19. All of us are in the same situation and we would like to let you know what we at Protak Scientific are doing to ensure the safety of our customers, employees and…
Bye Bye BI
An article that appeared in October edition of Cleanroom Technology Magazine The trouble with biological indicators. Understanding the challenge. The solution to continuous monitoring of “fragile” hydrogen peroxide decontamination processes. The trouble with biological indicators. For nearly forty years the pharmaceutical and healthcare sectors have used cold gaseous processes to deliver a decontamination of environments…
VHP (Vapour Hydrogen Peroxide) Fragility
Andrew Hopkins, senior GMP inspector, MHRA, explains the guidance around the use of vaporised hydrogen peroxide for sterilisation purposes The Medicines and Healthcare Products Regulatory Agency, MHRA, has released an article written by senior GMP inspector, Andrew Hopkins, which provides guidance around the use of vaporised hydrogen peroxide (VHP) for sterilisation purposes. Hopkins has…
Using Enzyme Indicators to validate decontamination measurement
The Editor of Cleanroom Technology caught up with Phillip Godden, founder and CEO at Protak about the use of this new technology and its support from the MHRA Previously the healthcare and pharmaceutical sectors used cold, gaseous processes to decontaminate environments. Likely the most notable of these methods is the hydrogen peroxide decontamination cycle, which offers excellent…
Global Healthcare and Pharmaceutical Magazine Feature – Phillip Godden
Phillip Godden was recently voted Pharmaceutical CEO of the Year. In this article Phillip describes the current processes and how Enzymatic Indicators can change the face of decontamination validation, as well as what has driven him to achieve Pharmaceutical CEO of the Year. Protak Scientific Limited is the world’s only vendor of Enzymatic Biological Indicators…
Phillip Godden voted Pharmaceutical CEO of the Year 2018
Phillip Godden, CEO of Protak Scientific has been awarded the coveted Pharmaceutical CEO of the Year 2018 by GHP magazine. The award recognises Phillip’s work in bringing Enzymatic Indicators to the pharmaceutical industry. Phillip is hugely passionate about bringing this technology to market as he believes it will revolutionise the medical and pharmaceutical industries’ approach to Decontamination Validation.…
Protak Scientific win Healthcare and Life Sciences 2018 award
Protak Scientific have won the Healthcare and Life Sciences 2018 award as the “Most Innovative in Decontamination Testing Services”. During the awards process over 90,000 Healthcare & Medical professionals, as well as the general public, were invited to nominate associations, companies & individuals based on their achievements over the previous 12 months. Additionally, Corporate Livewire’s…
Protak Scientific & the MHRA form an Enzymatic Indicator and Decontamination Validation Industry focus group
The MHRA have agreed to assist Protak Scientific in the formation of a UK focus group to discuss the use of Enzyme Indicators in the UK. The MHRA have seen the potential of the use of Enzymatic Indicators to measure Decontamination Validation and are open to discuss the regulation process with the group. Meetings will be via Social…
Protak Scientific invest in new purpose designed and built premises
Protak Scientific are delighted to announce that they will be shortly moving to brand new offices in Merstham, Surrey. Investing over a million pounds is never an easy decission however in the case of Protak Scientific it is the natural progression to support our growing multinational pharmaceutical customer base. Phillip Godden, CEO of Protak Scientific…
Tim Coles & Dr Helen Hale Article – Taming the Tyrannosaurus of Validation
Tim Coles, BSc (Hons), M.Phil., Technical Director, Pharminox Isolation Ltd., has worked in the field of isolator technology for over twenty years. He was a founding member of the UK Pharmaceutical Isolator Working Party that produced Pharmaceutical Isolators, Pharmaceutical Press, 2004, and more recently of the PDA committee that produced Technical Report No 51. “Biological…
Exclusive ISPE Decontamination & Validation ½ Day Workshop and Focus Group
An exclusive and prized opportunity to attend a ½ day workshop focused on decontamination processes and rapid validation using Enzymatic Biological Indicators. The event will bring industry experts together to learn about the most innovative technologies, with presentations such as: Tim Coles on the subject of Micro-Condensate Hydrogen Peroxide E-Beam Technology and the latest H2O2…
The Shortfalls Of Biological Indicators For HPV Decontamination Validation
The Vapour phase hydrogen peroxide (VPHP) process that is used for decontamination validation, conventionally uses Biological Indicators (BIs) to confirm decontamination has been achieved. This translates into a lengthy process (which can take up to weeks or even months) with highly detailed protocols to be executed that we believe are highly un-optimised, costly and risky.…
Protak Features In Clean Air & Containment Review
We are very excited with the increasing interest in our revolutionary technology. This month we feature heavily in the Clean Air & Containment Review with both an article on Enzyme Indicators by Tim Coles and a feature written by CEO Phillip Godden on the moment he discovered EI technology.</p> Tim Coles states that Enzyme indicators…
Protak Scientific At Pharma Integrates 2017 In November As Sponsor & Panelist
Protak Scientific at delighted to be attending Pharma Integrates 2017 on the 15th & 16th Nov at the Grange City Hotel, London. We are proud sponsors of this prestigious event and Protak CEO Phillip Godden will take his seat as a panelist on Day Two of the conference. You can view the agenda here. About…
Enzyme Indicators Proven As Viable Alternative For HPV Decontamination Validation
Enzyme Indicators (EI’s) have been proven as a revolutionary viable alternative to biological indicators (BI’s) for Hydrogen Peroxide decontamination validation. A white paper published today by the Parenteral Drug Association (PDA) Journal of Pharmaceutical Science & Technology, and written by Public Health England (PHE), states that Enzyme Indicators are a “potentially valuable tool for rapid…
Protak Scientific At The ISPE UK Summer Conference: Containment & Decontamination – 14/6
Protak Scientific along with Public Health England will attend this year’s ISPE UK Summer Conference which focuses on Containment & Decontamination. The event will be held on the 14th June 2017 at the National Conference Centre at the National Motorcycle Museum Coventry Road | Bickenhall | Solihull | West Midlands | B92 0EJ This 1…
Howorth Air Technology Trials Enzyme Indicators Successfully
We like to encourage all of our customers to trial Enzyme Indicators for decontamination validation alongside Biological Indicators when first considering this revolutionary technology. It’s vital that pharmaceutical companies have trust in the product and a clear indication of the benefits EI’s can bring versus the traditional biological indicators. Read on to see how Howorth…
Global Exclusive License Signed
After nearly 18 months of development and negotiation, we are pleased to announce that Protak Scientific have been selected to be the global exclusive partner for Public Health England (PHE) (which is an executive agency of the Department of Health in the United Kingdom), for the commercialisation and development of thermostable Adenylate Kinase for verification…
Global Exclusive License Signed
After nearly 18 months of development and negotiation, we are pleased to announce that Protak Scientific have been selected to be the global exclusive partner for Public Health England (PHE) (which is an executive agency of the Department of Health in the United Kingdom), for the commercialisation and development of thermostable Adenylate Kinase for verification…
Global Exclusive License Signed
After nearly 18 months of development and negotiation, we are pleased to announce that Protak Scientific have been selected to be the global exclusive partner for Public Health England (PHE) (which is an executive agency of the Department of Health in the United Kingdom), for the commercialisation and development of thermostable Adenylate Kinase for verification…
Global Exclusive License Signed
After nearly 18 months of development and negotiation, we are pleased to announce that Protak Scientific have been selected to be the global exclusive partner for Public Health England (PHE) (which is an executive agency of the Department of Health in the United Kingdom), for the commercialisation and development of thermostable Adenylate Kinase for verification…
Global Exclusive License Signed
After nearly 18 months of development and negotiation, we are pleased to announce that Protak Scientific have been selected to be the global exclusive partner for Public Health England (PHE) (which is an executive agency of the Department of Health in the United Kingdom), for the commercialisation and development of thermostable Adenylate Kinase for verification…
The North Carolina Board of Pharmacy has ordered a recall for all lots of non-sterile and sterile products
The North Carolina Board of Pharmacy has ordered a recall for all lots of non-sterile and sterile products compounded, repackaged and distributed by Prescription Center Pharmacy located at 915 Hay Street, Fayetteville, NC, between September 10, 2014, and March 10, 2015. Contact: Consumer: 919-246-1050 FOR IMMEDIATE RELEASE — April 1, 2015 — Fayetteville, NC —…
The North Carolina Board of Pharmacy has ordered a recall for all lots of non-sterile and sterile products
The North Carolina Board of Pharmacy has ordered a recall for all lots of non-sterile and sterile products compounded, repackaged and distributed by Prescription Center Pharmacy located at 915 Hay Street, Fayetteville, NC, between September 10, 2014, and March 10, 2015. Contact: Consumer: 919-246-1050 FOR IMMEDIATE RELEASE — April 1, 2015 — Fayetteville, NC —…
The North Carolina Board of Pharmacy has ordered a recall for all lots of non-sterile and sterile products
The North Carolina Board of Pharmacy has ordered a recall for all lots of non-sterile and sterile products compounded, repackaged and distributed by Prescription Center Pharmacy located at 915 Hay Street, Fayetteville, NC, between September 10, 2014, and March 10, 2015. Contact: Consumer: 919-246-1050 FOR IMMEDIATE RELEASE — April 1, 2015 — Fayetteville, NC —…
Compounded Sterile Drug Product Recalls Regarding Sterility and Quality Control
Compounded Sterile Drug Product Recalls Regarding Sterility and Quality Control – UPDATED April 2, 2015 FDA has alerted healthcare professionals and the public about multiple sterile compounding pharmacies having quality control and sterility issues. This alert does not include the New England Compounding Center information that was associated with fungal infections associated with their products.…
The North Carolina Board of Pharmacy has ordered a recall for all lots of non-sterile and sterile products
The North Carolina Board of Pharmacy has ordered a recall for all lots of non-sterile and sterile products compounded, repackaged and distributed by Prescription Center Pharmacy located at 915 Hay Street, Fayetteville, NC, between September 10, 2014, and March 10, 2015. Contact: Consumer: 919-246-1050 FOR IMMEDIATE RELEASE — April 1, 2015 — Fayetteville, NC —…
The North Carolina Board of Pharmacy has ordered a recall for all lots of non-sterile and sterile products
The North Carolina Board of Pharmacy has ordered a recall for all lots of non-sterile and sterile products compounded, repackaged and distributed by Prescription Center Pharmacy located at 915 Hay Street, Fayetteville, NC, between September 10, 2014, and March 10, 2015. Contact: Consumer: 919-246-1050 FOR IMMEDIATE RELEASE — April 1, 2015 — Fayetteville, NC —…
Protak trials with Public Health England in 2015
As part of the continual commitment to further research on Enzyme Indicators, Protak have commissioned Public Health England to further study tAK Enzyme Indicators
Compounded Sterile Drug Product Recalls Regarding Sterility and Quality Control
Compounded Sterile Drug Product Recalls Regarding Sterility and Quality Control – UPDATED April 2, 2015 FDA has alerted healthcare professionals and the public about multiple sterile compounding pharmacies having quality control and sterility issues. This alert does not include the New England Compounding Center information that was associated with fungal infections associated with their products.…
Compounded Sterile Drug Product Recalls Regarding Sterility and Quality Control
Compounded Sterile Drug Product Recalls Regarding Sterility and Quality Control – UPDATED April 2, 2015 FDA has alerted healthcare professionals and the public about multiple sterile compounding pharmacies having quality control and sterility issues. This alert does not include the New England Compounding Center information that was associated with fungal infections associated with their products.…
Protak trials with Public Health England in 2015
As part of the continual commitment to further research on Enzyme Indicators, Protak have commissioned Public Health England to further study tAK Enzyme Indicators
Protak trials with Public Health England in 2015
As part of the continual commitment to further research on Enzyme Indicators, Protak have commissioned Public Health England to further study tAK Enzyme Indicators
Compounded Sterile Drug Product Recalls Regarding Sterility and Quality Control
Compounded Sterile Drug Product Recalls Regarding Sterility and Quality Control – UPDATED April 2, 2015 FDA has alerted healthcare professionals and the public about multiple sterile compounding pharmacies having quality control and sterility issues. This alert does not include the New England Compounding Center information that was associated with fungal infections associated with their products.…
Protak trials with Public Health England in 2015
As part of the continual commitment to further research on Enzyme Indicators, Protak have commissioned Public Health England to further study tAK Enzyme Indicators
Compounded Sterile Drug Product Recalls Regarding Sterility and Quality Control
Compounded Sterile Drug Product Recalls Regarding Sterility and Quality Control – UPDATED April 2, 2015 FDA has alerted healthcare professionals and the public about multiple sterile compounding pharmacies having quality control and sterility issues. This alert does not include the New England Compounding Center information that was associated with fungal infections associated with their products.…
Protak trials with Public Health England in 2015
As part of the continual commitment to further research on Enzyme Indicators, Protak have commissioned Public Health England to further study tAK Enzyme Indicators
Applications Of Enzyme Indicators Versus Biological Indicators
The sterility test / verification of the performance of hydrogen peroxide decontamination is a vital process – yet the gold standard of Biological Indicators is incredibly flawed. With the introduction of Enzyme Indicators, a better option is finally available. One of several concerns with BIs, especially when high-value products are handled, is the risk of…
Hospira Issues a Voluntary Recall Due to Mold Contamination
FDA PRESS RELEASE, FOR IMMEDIATE RELEASE — March 11, 2015 — LAKE FOREST, Ill. — Hospira, Inc. (NYSE: HSP), announced today it is initiating a voluntary recall of one lot of Lactated Ringer’s Irrigation, 3000mL (NDC 0409-7828-08, Lot 40-008-JT; Expiry 1APR2016) to the user level (both human and veterinary) due to a confirmed customer report…
Hospira Issues a Voluntary Recall Due to Mold Contamination
FDA PRESS RELEASE, FOR IMMEDIATE RELEASE — March 11, 2015 — LAKE FOREST, Ill. — Hospira, Inc. (NYSE: HSP), announced today it is initiating a voluntary recall of one lot of Lactated Ringer’s Irrigation, 3000mL (NDC 0409-7828-08, Lot 40-008-JT; Expiry 1APR2016) to the user level (both human and veterinary) due to a confirmed customer report…
Applications Of Enzyme Indicators Versus Biological Indicators
The sterility test / verification of the performance of hydrogen peroxide decontamination is a vital process – yet the gold standard of Biological Indicators is incredibly flawed. With the introduction of Enzyme Indicators, a better option is finally available. One of several concerns with BIs, especially when high-value products are handled, is the risk of…
Hospira Issues a Voluntary Recall Due to Mold Contamination
FDA PRESS RELEASE, FOR IMMEDIATE RELEASE — March 11, 2015 — LAKE FOREST, Ill. — Hospira, Inc. (NYSE: HSP), announced today it is initiating a voluntary recall of one lot of Lactated Ringer’s Irrigation, 3000mL (NDC 0409-7828-08, Lot 40-008-JT; Expiry 1APR2016) to the user level (both human and veterinary) due to a confirmed customer report…
Applications Of Enzyme Indicators Versus Biological Indicators
The sterility test / verification of the performance of hydrogen peroxide decontamination is a vital process – yet the gold standard of Biological Indicators is incredibly flawed. With the introduction of Enzyme Indicators, a better option is finally available. One of several concerns with BIs, especially when high-value products are handled, is the risk of…
Hospira Issues a Voluntary Recall Due to Mold Contamination
FDA PRESS RELEASE, FOR IMMEDIATE RELEASE — March 11, 2015 — LAKE FOREST, Ill. — Hospira, Inc. (NYSE: HSP), announced today it is initiating a voluntary recall of one lot of Lactated Ringer’s Irrigation, 3000mL (NDC 0409-7828-08, Lot 40-008-JT; Expiry 1APR2016) to the user level (both human and veterinary) due to a confirmed customer report…
Applications Of Enzyme Indicators Versus Biological Indicators
The sterility test / verification of the performance of hydrogen peroxide decontamination is a vital process – yet the gold standard of Biological Indicators is incredibly flawed. With the introduction of Enzyme Indicators, a better option is finally available. One of several concerns with BIs, especially when high-value products are handled, is the risk of…
Applications Of Enzyme Indicators Versus Biological Indicators
The sterility test / verification of the performance of hydrogen peroxide decontamination is a vital process – yet the gold standard of Biological Indicators is incredibly flawed. With the introduction of Enzyme Indicators, a better option is finally available. One of several concerns with BIs, especially when high-value products are handled, is the risk of…
Hospira Issues a Voluntary Recall Due to Mold Contamination
FDA PRESS RELEASE, FOR IMMEDIATE RELEASE — March 11, 2015 — LAKE FOREST, Ill. — Hospira, Inc. (NYSE: HSP), announced today it is initiating a voluntary recall of one lot of Lactated Ringer’s Irrigation, 3000mL (NDC 0409-7828-08, Lot 40-008-JT; Expiry 1APR2016) to the user level (both human and veterinary) due to a confirmed customer report…
Phillip Godden CEO, On Protak, His Passion And Why Enzyme Indicators Are The Future
Read what Protak’s CEO Phillip Godden has to say about his company, the new Enzyme Indicator technology and why he is so passionate to bring it to market worldwide… So what do you know about this industry? I’d love to say that aseptic pharmaceutical manufacturing was my chosen subject matter – and that I’m…
Phillip Godden CEO, On Protak, His Passion And Why Enzyme Indicators Are The Future
Read what Protak’s CEO Phillip Godden has to say about his company, the new Enzyme Indicator technology and why he is so passionate to bring it to market worldwide… So what do you know about this industry? I’d love to say that aseptic pharmaceutical manufacturing was my chosen subject matter – and that I’m…
Phillip Godden CEO, On Protak, His Passion And Why Enzyme Indicators Are The Future
Read what Protak’s CEO Phillip Godden has to say about his company, the new Enzyme Indicator technology and why he is so passionate to bring it to market worldwide… So what do you know about this industry? I’d love to say that aseptic pharmaceutical manufacturing was my chosen subject matter – and that I’m…
Phillip Godden CEO, On Protak, His Passion And Why Enzyme Indicators Are The Future
Read what Protak’s CEO Phillip Godden has to say about his company, the new Enzyme Indicator technology and why he is so passionate to bring it to market worldwide… So what do you know about this industry? I’d love to say that aseptic pharmaceutical manufacturing was my chosen subject matter – and that I’m…
FDA alert – Voluntary Recall – Potential Impact on Product Sterility
ISSUE: Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of two lots of Atracurium Besylate Injection, USP, 50mg/5mL single-dose vials (NDC 25021-659-05) and four lots of Atracurium Besylate Injection, USP, 100mg/10mL multi-dose vials (NDC 25021-672-10) manufactured by Emcure Pharmaceuticals Ltd. and distributed by Sagent. Sagent has initiated this voluntary recall of Atracurium Besylate Injection, USP,…
Phillip Godden CEO, On Protak, His Passion And Why Enzyme Indicators Are The Future
Read what Protak’s CEO Phillip Godden has to say about his company, the new Enzyme Indicator technology and why he is so passionate to bring it to market worldwide… So what do you know about this industry? I’d love to say that aseptic pharmaceutical manufacturing was my chosen subject matter – and that I’m…
The Real Value Of Using Enzyme Indicators For Decontamination Validation
So where can the use of Enzyme Indicators for decontamination validation bring real value? Here we discuss some key areas where this new science will revolutionise current processes… EI’s with pharmaceutical isolators or spaces that use VHP or HPV for decontamination EI’s start bringing value in the very early days for equipment manufacturers when…
The Real Value Of Using Enzyme Indicators For Decontamination Validation
So where can the use of Enzyme Indicators for decontamination validation bring real value? Here we discuss some key areas where this new science will revolutionise current processes… EI’s with pharmaceutical isolators or spaces that use VHP or HPV for decontamination EI’s start bringing value in the very early days for equipment manufacturers when…
FDA alert – Voluntary Recall – Potential Impact on Product Sterility
ISSUE: Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of two lots of Atracurium Besylate Injection, USP, 50mg/5mL single-dose vials (NDC 25021-659-05) and four lots of Atracurium Besylate Injection, USP, 100mg/10mL multi-dose vials (NDC 25021-672-10) manufactured by Emcure Pharmaceuticals Ltd. and distributed by Sagent. Sagent has initiated this voluntary recall of Atracurium Besylate Injection, USP,…
The Real Value Of Using Enzyme Indicators For Decontamination Validation
So where can the use of Enzyme Indicators for decontamination validation bring real value? Here we discuss some key areas where this new science will revolutionise current processes… EI’s with pharmaceutical isolators or spaces that use VHP or HPV for decontamination EI’s start bringing value in the very early days for equipment manufacturers when…
FDA alert – Voluntary Recall – Potential Impact on Product Sterility
ISSUE: Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of two lots of Atracurium Besylate Injection, USP, 50mg/5mL single-dose vials (NDC 25021-659-05) and four lots of Atracurium Besylate Injection, USP, 100mg/10mL multi-dose vials (NDC 25021-672-10) manufactured by Emcure Pharmaceuticals Ltd. and distributed by Sagent. Sagent has initiated this voluntary recall of Atracurium Besylate Injection, USP,…
The Real Value Of Using Enzyme Indicators For Decontamination Validation
So where can the use of Enzyme Indicators for decontamination validation bring real value? Here we discuss some key areas where this new science will revolutionise current processes… EI’s with pharmaceutical isolators or spaces that use VHP or HPV for decontamination EI’s start bringing value in the very early days for equipment manufacturers when…
The Real Value Of Using Enzyme Indicators For Decontamination Validation
So where can the use of Enzyme Indicators for decontamination validation bring real value? Here we discuss some key areas where this new science will revolutionise current processes… EI’s with pharmaceutical isolators or spaces that use VHP or HPV for decontamination EI’s start bringing value in the very early days for equipment manufacturers when…
What Are Biological Indicators?
Biological indicators were the foremost method of assessing the sterility of any medical or pharmaceutical environment through the use of some of the most resistant microorganism strains (eg. Bacillus or Geobacillus), rather than simply relying on meeting the requirements of both physical and chemical sterilization. As the microorganisms used as biological indicators present in higher concentration…
FDA alert – Voluntary Recall – Potential Impact on Product Sterility
ISSUE: Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of two lots of Atracurium Besylate Injection, USP, 50mg/5mL single-dose vials (NDC 25021-659-05) and four lots of Atracurium Besylate Injection, USP, 100mg/10mL multi-dose vials (NDC 25021-672-10) manufactured by Emcure Pharmaceuticals Ltd. and distributed by Sagent. Sagent has initiated this voluntary recall of Atracurium Besylate Injection, USP,…
What Are Biological Indicators?
Biological indicators were the foremost method of assessing the sterility of any medical or pharmaceutical environment through the use of some of the most resistant microorganism strains (eg. Bacillus or Geobacillus), rather than simply relying on meeting the requirements of both physical and chemical sterilization. As the microorganisms used as biological indicators present in higher concentration…
FDA alert – Voluntary Recall – Potential Impact on Product Sterility
ISSUE: Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of two lots of Atracurium Besylate Injection, USP, 50mg/5mL single-dose vials (NDC 25021-659-05) and four lots of Atracurium Besylate Injection, USP, 100mg/10mL multi-dose vials (NDC 25021-672-10) manufactured by Emcure Pharmaceuticals Ltd. and distributed by Sagent. Sagent has initiated this voluntary recall of Atracurium Besylate Injection, USP,…
What Are Biological Indicators?
Biological indicators were the foremost method of assessing the sterility of any medical or pharmaceutical environment through the use of some of the most resistant microorganism strains (eg. Bacillus or Geobacillus), rather than simply relying on meeting the requirements of both physical and chemical sterilization. As the microorganisms used as biological indicators present in higher concentration…
What Are Biological Indicators?
Biological indicators were the foremost method of assessing the sterility of any medical or pharmaceutical environment through the use of some of the most resistant microorganism strains (eg. Bacillus or Geobacillus), rather than simply relying on meeting the requirements of both physical and chemical sterilization. As the microorganisms used as biological indicators present in higher concentration…
Heritage Initiates a Voluntary Recall Due to a Lack of Sterility Assurance
FDA PRESS, FOR IMMEDIATE RELEASE — February 24, 2015 — Eatontown, NJ, Heritage Pharmaceuticals Inc. (Heritage) today announced the voluntary nationwide recall of ten (10) lots of Colistimethate for Injection, USP, 150 mg Single-Dose vial (NDC 23155-193-31) and three (3) lots of Rifampin for Injection, USP, 600 mg Single-Dose vial (NDC 23155-340-31) manufactured by Emcure…
What Are Biological Indicators?
Biological indicators were the foremost method of assessing the sterility of any medical or pharmaceutical environment through the use of some of the most resistant microorganism strains (eg. Bacillus or Geobacillus), rather than simply relying on meeting the requirements of both physical and chemical sterilization. As the microorganisms used as biological indicators present in higher concentration…
Phillip Godden On The Moment He Discovered An Industry-Changing Alternative To Biological Indicators
By Phillip Godden, CEO, Protak Scientific First off, thanks for taking a few moments to click through and read more. I wanted to pen a few words about me, this technology and the excitement it has generated for me and I hope you too when you share the same moment I had a few years ago.…
Heritage Initiates a Voluntary Recall Due to a Lack of Sterility Assurance
FDA PRESS, FOR IMMEDIATE RELEASE — February 24, 2015 — Eatontown, NJ, Heritage Pharmaceuticals Inc. (Heritage) today announced the voluntary nationwide recall of ten (10) lots of Colistimethate for Injection, USP, 150 mg Single-Dose vial (NDC 23155-193-31) and three (3) lots of Rifampin for Injection, USP, 600 mg Single-Dose vial (NDC 23155-340-31) manufactured by Emcure…
Heritage Initiates a Voluntary Recall Due to a Lack of Sterility Assurance
FDA PRESS, FOR IMMEDIATE RELEASE — February 24, 2015 — Eatontown, NJ, Heritage Pharmaceuticals Inc. (Heritage) today announced the voluntary nationwide recall of ten (10) lots of Colistimethate for Injection, USP, 150 mg Single-Dose vial (NDC 23155-193-31) and three (3) lots of Rifampin for Injection, USP, 600 mg Single-Dose vial (NDC 23155-340-31) manufactured by Emcure…
Phillip Godden On The Moment He Discovered An Industry-Changing Alternative To Biological Indicators
By Phillip Godden, CEO, Protak Scientific First off, thanks for taking a few moments to click through and read more. I wanted to pen a few words about me, this technology and the excitement it has generated for me and I hope you too when you share the same moment I had a few years ago.…
Heritage Initiates a Voluntary Recall Due to a Lack of Sterility Assurance
FDA PRESS, FOR IMMEDIATE RELEASE — February 24, 2015 — Eatontown, NJ, Heritage Pharmaceuticals Inc. (Heritage) today announced the voluntary nationwide recall of ten (10) lots of Colistimethate for Injection, USP, 150 mg Single-Dose vial (NDC 23155-193-31) and three (3) lots of Rifampin for Injection, USP, 600 mg Single-Dose vial (NDC 23155-340-31) manufactured by Emcure…
Heritage Initiates a Voluntary Recall Due to a Lack of Sterility Assurance
FDA PRESS, FOR IMMEDIATE RELEASE — February 24, 2015 — Eatontown, NJ, Heritage Pharmaceuticals Inc. (Heritage) today announced the voluntary nationwide recall of ten (10) lots of Colistimethate for Injection, USP, 150 mg Single-Dose vial (NDC 23155-193-31) and three (3) lots of Rifampin for Injection, USP, 600 mg Single-Dose vial (NDC 23155-340-31) manufactured by Emcure…
Phillip Godden On The Moment He Discovered An Industry-Changing Alternative To Biological Indicators
By Phillip Godden, CEO, Protak Scientific First off, thanks for taking a few moments to click through and read more. I wanted to pen a few words about me, this technology and the excitement it has generated for me and I hope you too when you share the same moment I had a few years ago.…
Phillip Godden On The Moment He Discovered An Industry-Changing Alternative To Biological Indicators
By Phillip Godden, CEO, Protak Scientific First off, thanks for taking a few moments to click through and read more. I wanted to pen a few words about me, this technology and the excitement it has generated for me and I hope you too when you share the same moment I had a few years ago.…
Phillip Godden On The Moment He Discovered An Industry-Changing Alternative To Biological Indicators
By Phillip Godden, CEO, Protak Scientific First off, thanks for taking a few moments to click through and read more. I wanted to pen a few words about me, this technology and the excitement it has generated for me and I hope you too when you share the same moment I had a few years ago.…
Potential contamination with Bacillus cereus
ITH Pharma Ltd is recalling specific batches of Lipid Phase Parenteral Nutrition from specific hospitals. This is because of a potential contamination with Bacillus cereus identified following a small number of reported cases of Bacillus cereus septicaemia affecting neonates. All batches have expired and it is believed that there is little or no stock remaining…
Protak Scientific Announce Appointment of Netsteril As Distributor for Spain To Supply Revolutionary Alternative To Biological Indicators
Protak Scientific, the UK company leading the introduction of a revolutionary new science in decontamination validation worldwide, the Enzyme Indicator, have appointed Netsteril to bring the technology to Spain. Enzyme Indicators are a new, viable and instant alternative to the current biological indicators used in decontamination validation. The 7-day waiting time to get the results…
Potential contamination with Bacillus cereus
ITH Pharma Ltd is recalling specific batches of Lipid Phase Parenteral Nutrition from specific hospitals. This is because of a potential contamination with Bacillus cereus identified following a small number of reported cases of Bacillus cereus septicaemia affecting neonates. All batches have expired and it is believed that there is little or no stock remaining…
Potential contamination with Bacillus cereus
ITH Pharma Ltd is recalling specific batches of Lipid Phase Parenteral Nutrition from specific hospitals. This is because of a potential contamination with Bacillus cereus identified following a small number of reported cases of Bacillus cereus septicaemia affecting neonates. All batches have expired and it is believed that there is little or no stock remaining…
Protak Scientific Announce Appointment of Netsteril As Distributor for Spain To Supply Revolutionary Alternative To Biological Indicators
Protak Scientific, the UK company leading the introduction of a revolutionary new science in decontamination validation worldwide, the Enzyme Indicator, have appointed Netsteril to bring the technology to Spain. Enzyme Indicators are a new, viable and instant alternative to the current biological indicators used in decontamination validation. The 7-day waiting time to get the results…
Potential contamination with Bacillus cereus
ITH Pharma Ltd is recalling specific batches of Lipid Phase Parenteral Nutrition from specific hospitals. This is because of a potential contamination with Bacillus cereus identified following a small number of reported cases of Bacillus cereus septicaemia affecting neonates. All batches have expired and it is believed that there is little or no stock remaining…
Protak Scientific Announce Appointment of Netsteril As Distributor for Spain To Supply Revolutionary Alternative To Biological Indicators
Protak Scientific, the UK company leading the introduction of a revolutionary new science in decontamination validation worldwide, the Enzyme Indicator, have appointed Netsteril to bring the technology to Spain. Enzyme Indicators are a new, viable and instant alternative to the current biological indicators used in decontamination validation. The 7-day waiting time to get the results…
Protak Scientific Announce Appointment of Netsteril As Distributor for Spain To Supply Revolutionary Alternative To Biological Indicators
Protak Scientific, the UK company leading the introduction of a revolutionary new science in decontamination validation worldwide, the Enzyme Indicator, have appointed Netsteril to bring the technology to Spain. Enzyme Indicators are a new, viable and instant alternative to the current biological indicators used in decontamination validation. The 7-day waiting time to get the results…
Potential contamination with Bacillus cereus
ITH Pharma Ltd is recalling specific batches of Lipid Phase Parenteral Nutrition from specific hospitals. This is because of a potential contamination with Bacillus cereus identified following a small number of reported cases of Bacillus cereus septicaemia affecting neonates. All batches have expired and it is believed that there is little or no stock remaining…
Protak Scientific Announce Appointment of Netsteril As Distributor for Spain To Supply Revolutionary Alternative To Biological Indicators
Protak Scientific, the UK company leading the introduction of a revolutionary new science in decontamination validation worldwide, the Enzyme Indicator, have appointed Netsteril to bring the technology to Spain. Enzyme Indicators are a new, viable and instant alternative to the current biological indicators used in decontamination validation. The 7-day waiting time to get the results…
Global Exclusive License Signed
After nearly 18 months of development and negotiation, we are pleased to announce that Protak Scientific have been selected to be the global exclusive partner for Public Health England (PHE) (which is an executive agency of the Department of Health in the United Kingdom), for the commercialisation and development of thermostable Adenylate Kinase for verification…
Compounded Sterile Drug Product Recalls Regarding Sterility and Quality Control
Compounded Sterile Drug Product Recalls Regarding Sterility and Quality Control – UPDATED April 2, 2015 FDA has alerted healthcare professionals and the public about multiple sterile compounding pharmacies having quality control and sterility issues. This alert does not include the New England Compounding Center information that was associated with fungal infections associated with their products.…
Protak trials with Public Health England in 2015
As part of the continual commitment to further research on Enzyme Indicators, Protak have commissioned Public Health England to further study tAK Enzyme Indicators
Protak trials with Public Health England in 2015
As part of the continual commitment to further research on Enzyme Indicators, Protak have commissioned Public Health England to further study tAK Enzyme Indicators
Global Exclusive License Signed
After nearly 18 months of development and negotiation, we are pleased to announce that Protak Scientific have been selected to be the global exclusive partner for Public Health England (PHE) (which is an executive agency of the Department of Health in the United Kingdom), for the commercialisation and development of thermostable Adenylate Kinase for verification…
The North Carolina Board of Pharmacy has ordered a recall for all lots of non-sterile and sterile products
The North Carolina Board of Pharmacy has ordered a recall for all lots of non-sterile and sterile products compounded, repackaged and distributed by Prescription Center Pharmacy located at 915 Hay Street, Fayetteville, NC, between September 10, 2014, and March 10, 2015. Contact: Consumer: 919-246-1050 FOR IMMEDIATE RELEASE — April 1, 2015 — Fayetteville, NC —…
The North Carolina Board of Pharmacy has ordered a recall for all lots of non-sterile and sterile products
The North Carolina Board of Pharmacy has ordered a recall for all lots of non-sterile and sterile products compounded, repackaged and distributed by Prescription Center Pharmacy located at 915 Hay Street, Fayetteville, NC, between September 10, 2014, and March 10, 2015. Contact: Consumer: 919-246-1050 FOR IMMEDIATE RELEASE — April 1, 2015 — Fayetteville, NC —…
Compounded Sterile Drug Product Recalls Regarding Sterility and Quality Control
Compounded Sterile Drug Product Recalls Regarding Sterility and Quality Control – UPDATED April 2, 2015 FDA has alerted healthcare professionals and the public about multiple sterile compounding pharmacies having quality control and sterility issues. This alert does not include the New England Compounding Center information that was associated with fungal infections associated with their products.…
Hospira Issues a Voluntary Recall Due to Mold Contamination
FDA PRESS RELEASE, FOR IMMEDIATE RELEASE — March 11, 2015 — LAKE FOREST, Ill. — Hospira, Inc. (NYSE: HSP), announced today it is initiating a voluntary recall of one lot of Lactated Ringer’s Irrigation, 3000mL (NDC 0409-7828-08, Lot 40-008-JT; Expiry 1APR2016) to the user level (both human and veterinary) due to a confirmed customer report…
FDA alert – Voluntary Recall – Potential Impact on Product Sterility
ISSUE: Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of two lots of Atracurium Besylate Injection, USP, 50mg/5mL single-dose vials (NDC 25021-659-05) and four lots of Atracurium Besylate Injection, USP, 100mg/10mL multi-dose vials (NDC 25021-672-10) manufactured by Emcure Pharmaceuticals Ltd. and distributed by Sagent. Sagent has initiated this voluntary recall of Atracurium Besylate Injection, USP,…
Heritage Initiates a Voluntary Recall Due to a Lack of Sterility Assurance
FDA PRESS, FOR IMMEDIATE RELEASE — February 24, 2015 — Eatontown, NJ, Heritage Pharmaceuticals Inc. (Heritage) today announced the voluntary nationwide recall of ten (10) lots of Colistimethate for Injection, USP, 150 mg Single-Dose vial (NDC 23155-193-31) and three (3) lots of Rifampin for Injection, USP, 600 mg Single-Dose vial (NDC 23155-340-31) manufactured by Emcure…
Hospira Issues a Voluntary Recall Due to Mold Contamination
FDA PRESS RELEASE, FOR IMMEDIATE RELEASE — March 11, 2015 — LAKE FOREST, Ill. — Hospira, Inc. (NYSE: HSP), announced today it is initiating a voluntary recall of one lot of Lactated Ringer’s Irrigation, 3000mL (NDC 0409-7828-08, Lot 40-008-JT; Expiry 1APR2016) to the user level (both human and veterinary) due to a confirmed customer report…
Heritage Initiates a Voluntary Recall Due to a Lack of Sterility Assurance
FDA PRESS, FOR IMMEDIATE RELEASE — February 24, 2015 — Eatontown, NJ, Heritage Pharmaceuticals Inc. (Heritage) today announced the voluntary nationwide recall of ten (10) lots of Colistimethate for Injection, USP, 150 mg Single-Dose vial (NDC 23155-193-31) and three (3) lots of Rifampin for Injection, USP, 600 mg Single-Dose vial (NDC 23155-340-31) manufactured by Emcure…
FDA alert – Voluntary Recall – Potential Impact on Product Sterility
ISSUE: Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of two lots of Atracurium Besylate Injection, USP, 50mg/5mL single-dose vials (NDC 25021-659-05) and four lots of Atracurium Besylate Injection, USP, 100mg/10mL multi-dose vials (NDC 25021-672-10) manufactured by Emcure Pharmaceuticals Ltd. and distributed by Sagent. Sagent has initiated this voluntary recall of Atracurium Besylate Injection, USP,…
Potential contamination with Bacillus cereus
ITH Pharma Ltd is recalling specific batches of Lipid Phase Parenteral Nutrition from specific hospitals. This is because of a potential contamination with Bacillus cereus identified following a small number of reported cases of Bacillus cereus septicaemia affecting neonates. All batches have expired and it is believed that there is little or no stock remaining…
Applications Of Enzyme Indicators Versus Biological Indicators
The sterility test / verification of the performance of hydrogen peroxide decontamination is a vital process – yet the gold standard of Biological Indicators is incredibly flawed. With the introduction of Enzyme Indicators, a better option is finally available. One of several concerns with BIs, especially when high-value products are handled, is the risk of…
Applications Of Enzyme Indicators Versus Biological Indicators
The sterility test / verification of the performance of hydrogen peroxide decontamination is a vital process – yet the gold standard of Biological Indicators is incredibly flawed. With the introduction of Enzyme Indicators, a better option is finally available. One of several concerns with BIs, especially when high-value products are handled, is the risk of…
Phillip Godden CEO, On Protak, His Passion And Why Enzyme Indicators Are The Future
Read what Protak’s CEO Phillip Godden has to say about his company, the new Enzyme Indicator technology and why he is so passionate to bring it to market worldwide… So what do you know about this industry? I’d love to say that aseptic pharmaceutical manufacturing was my chosen subject matter – and that I’m…
Phillip Godden CEO, On Protak, His Passion And Why Enzyme Indicators Are The Future
Read what Protak’s CEO Phillip Godden has to say about his company, the new Enzyme Indicator technology and why he is so passionate to bring it to market worldwide… So what do you know about this industry? I’d love to say that aseptic pharmaceutical manufacturing was my chosen subject matter – and that I’m…
The Real Value Of Using Enzyme Indicators For Decontamination Validation
So where can the use of Enzyme Indicators for decontamination validation bring real value? Here we discuss some key areas where this new science will revolutionise current processes… EI’s with pharmaceutical isolators or spaces that use VHP or HPV for decontamination EI’s start bringing value in the very early days for equipment manufacturers when…
The Real Value Of Using Enzyme Indicators For Decontamination Validation
So where can the use of Enzyme Indicators for decontamination validation bring real value? Here we discuss some key areas where this new science will revolutionise current processes… EI’s with pharmaceutical isolators or spaces that use VHP or HPV for decontamination EI’s start bringing value in the very early days for equipment manufacturers when…
What Are Biological Indicators?
Biological indicators were the foremost method of assessing the sterility of any medical or pharmaceutical environment through the use of some of the most resistant microorganism strains (eg. Bacillus or Geobacillus), rather than simply relying on meeting the requirements of both physical and chemical sterilization. As the microorganisms used as biological indicators present in higher concentration…
What Are Biological Indicators?
Biological indicators were the foremost method of assessing the sterility of any medical or pharmaceutical environment through the use of some of the most resistant microorganism strains (eg. Bacillus or Geobacillus), rather than simply relying on meeting the requirements of both physical and chemical sterilization. As the microorganisms used as biological indicators present in higher concentration…
Phillip Godden On The Moment He Discovered An Industry-Changing Alternative To Biological Indicators
By Phillip Godden, CEO, Protak Scientific First off, thanks for taking a few moments to click through and read more. I wanted to pen a few words about me, this technology and the excitement it has generated for me and I hope you too when you share the same moment I had a few years ago.…
Phillip Godden On The Moment He Discovered An Industry-Changing Alternative To Biological Indicators
By Phillip Godden, CEO, Protak Scientific First off, thanks for taking a few moments to click through and read more. I wanted to pen a few words about me, this technology and the excitement it has generated for me and I hope you too when you share the same moment I had a few years ago.…
Protak Scientific Announce Appointment of Netsteril As Distributor for Spain To Supply Revolutionary Alternative To Biological Indicators
Protak Scientific, the UK company leading the introduction of a revolutionary new science in decontamination validation worldwide, the Enzyme Indicator, have appointed Netsteril to bring the technology to Spain. Enzyme Indicators are a new, viable and instant alternative to the current biological indicators used in decontamination validation. The 7-day waiting time to get the results…
Protak Scientific Announce Appointment of Netsteril As Distributor for Spain To Supply Revolutionary Alternative To Biological Indicators
Protak Scientific, the UK company leading the introduction of a revolutionary new science in decontamination validation worldwide, the Enzyme Indicator, have appointed Netsteril to bring the technology to Spain. Enzyme Indicators are a new, viable and instant alternative to the current biological indicators used in decontamination validation. The 7-day waiting time to get the results…
Clean Air & Containment Review – “EI’s Will Eventually Take Over BI’s”
Tim Coles, writing in Clean Air and Containment Review has covered the use of Enzyme Indicators in HPV decontamination processes in his article “Sanitisation with vapour phase hydrogen peroxide – practical cycle development and future improvements.” His view was “Given the very significant advantages of EIs it seems likely that they will eventually take over…
Protak Scientific Announce Appointment of Netsteril As Distributor for Spain To Supply Revolutionary Alternative To Biological Indicators
Protak Scientific, the UK company leading the introduction of a revolutionary new science in decontamination validation worldwide, the Enzyme Indicator, have appointed Netsteril to bring the technology to Spain. Enzyme Indicators are a new, viable and instant alternative to the current biological indicators used in decontamination validation. The 7-day waiting time to get the results…
Phillip Godden On The Moment He Discovered An Industry-Changing Alternative To Biological Indicators
By Phillip Godden, CEO, Protak Scientific First off, thanks for taking a few moments to click through and read more. I wanted to pen a few words about me, this technology and the excitement it has generated for me and I hope you too when you share the same moment I had a few years ago.…
What Are Biological Indicators?
Biological indicators were the foremost method of assessing the sterility of any medical or pharmaceutical environment through the use of some of the most resistant microorganism strains (eg. Bacillus or Geobacillus), rather than simply relying on meeting the requirements of both physical and chemical sterilization. As the microorganisms used as biological indicators present in higher concentration…
The Real Value Of Using Enzyme Indicators For Decontamination Validation
So where can the use of Enzyme Indicators for decontamination validation bring real value? Here we discuss some key areas where this new science will revolutionise current processes… EI’s with pharmaceutical isolators or spaces that use VHP or HPV for decontamination EI’s start bringing value in the very early days for equipment manufacturers when developing…
Phillip Godden CEO, On Protak, His Passion And Why Enzyme Indicators Are The Future
Read what Protak’s CEO Phillip Godden has to say about his company, the new Enzyme Indicator technology and why he is so passionate to bring it to market worldwide… So what do you know about this industry? I’d love to say that aseptic pharmaceutical manufacturing was my chosen subject matter – and that I’m…
Applications Of Enzyme Indicators Versus Biological Indicators
The sterility test / verification of the performance of hydrogen peroxide decontamination is a vital process – yet the gold standard of Biological Indicators is incredibly flawed. With the introduction of Enzyme Indicators, a better option is finally available. One of several concerns with BIs, especially when high-value products are handled, is the risk of…
Compounded Sterile Drug Product Recalls Regarding Sterility and Quality Control
Compounded Sterile Drug Product Recalls Regarding Sterility and Quality Control – UPDATED April 2, 2015 FDA has alerted healthcare professionals and the public about multiple sterile compounding pharmacies having quality control and sterility issues. This alert does not include the New England Compounding Center information that was associated with fungal infections associated with their products.…
The North Carolina Board of Pharmacy has ordered a recall for all lots of non-sterile and sterile products
The North Carolina Board of Pharmacy has ordered a recall for all lots of non-sterile and sterile products compounded, repackaged and distributed by Prescription Center Pharmacy located at 915 Hay Street, Fayetteville, NC, between September 10, 2014, and March 10, 2015. Contact: Consumer: 919-246-1050 FOR IMMEDIATE RELEASE — April 1, 2015 — Fayetteville, NC —…
Global Exclusive License Signed
After nearly 18 months of development and negotiation, we are pleased to announce that Protak Scientific have been selected to be the global exclusive partner for Public Health England (PHE) (which is an executive agency of the Department of Health in the United Kingdom), for the commercialisation and development of thermostable Adenylate Kinase for verification…
Protak trials with Public Health England in 2015
As part of the continual commitment to further research on Enzyme Indicators, Protak have commissioned Public Health England to further study tAK Enzyme Indicators
Hospira Issues a Voluntary Recall Due to Mold Contamination
FDA PRESS RELEASE, FOR IMMEDIATE RELEASE — March 11, 2015 — LAKE FOREST, Ill. — Hospira, Inc. (NYSE: HSP), announced today it is initiating a voluntary recall of one lot of Lactated Ringer’s Irrigation, 3000mL (NDC 0409-7828-08, Lot 40-008-JT; Expiry 1APR2016) to the user level (both human and veterinary) due to a confirmed customer report…
FDA alert – Voluntary Recall – Potential Impact on Product Sterility
ISSUE: Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of two lots of Atracurium Besylate Injection, USP, 50mg/5mL single-dose vials (NDC 25021-659-05) and four lots of Atracurium Besylate Injection, USP, 100mg/10mL multi-dose vials (NDC 25021-672-10) manufactured by Emcure Pharmaceuticals Ltd. and distributed by Sagent. Sagent has initiated this voluntary recall of Atracurium Besylate Injection, USP,…
Heritage Initiates a Voluntary Recall Due to a Lack of Sterility Assurance
FDA PRESS, FOR IMMEDIATE RELEASE — February 24, 2015 — Eatontown, NJ, Heritage Pharmaceuticals Inc. (Heritage) today announced the voluntary nationwide recall of ten (10) lots of Colistimethate for Injection, USP, 150 mg Single-Dose vial (NDC 23155-193-31) and three (3) lots of Rifampin for Injection, USP, 600 mg Single-Dose vial (NDC 23155-340-31) manufactured by Emcure…
Potential contamination with Bacillus cereus
ITH Pharma Ltd is recalling specific batches of Lipid Phase Parenteral Nutrition from specific hospitals. This is because of a potential contamination with Bacillus cereus identified following a small number of reported cases of Bacillus cereus septicaemia affecting neonates. All batches have expired and it is believed that there is little or no stock remaining…