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 […]

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 […]

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, […]

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 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. […]