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 […]
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 […]
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 […]
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 […]
