Evaluation of residual moisture in lyocakes and corresponding lyophilization stoppers of different rubber formulations

Dr. Heike Kofler, Amy Miller, Jennifer Riter West Pharmaceutical Services, Inc. One of the critical success factors for packaging lyophilized drugs is protection against product degradation caused by moisture. Moisture can be introduced into a lyophilized drug product cake from the elastomeric stopper and from the atmospheric headspace; it can also permeate through the stopper, [...]

Quality Performance of Advanced Cyclic Olefin Plastic Prefillable Syringes

Tibor Hlobik, Director, Prefillable Solutions and Technologies Mike Gills, Customer Technical Support Process Engineer Growth in biopharmaceutical therapeutics is leading innovation with prefillable syringe systems. These complex sensitive drug products require highly inert primary packaging materials for improved stability and delivery in perfect quality for reduced safety risk. This poster will provide a quality comparison [...]

The Effect of a Barrier Film on Elastomeric Extractables in a Parenteral Packaging System

Amy Miller and Jennifer Riter Extractables from elastomeric components become an issue even before a pharmaceutical drug makes contact with the elastomeric component. The suitability of the elastomer and the drug product needs to be taken into consideration at the development stage of the packaging and delivery system for the drug product. The potential for [...]

The Effects of Ozone and Various Sterilization Techniques on Elastomeric Rubber Needle Shields and Tip Caps

J. Riter, A. Janssen, D. Engels Cracking of elastomeric needle shields and tip caps is a costly problem for pharmaceutical manufacturers. Cracked components can cause leaks that can result in loss of drug potency and sterility and may lead to a safety risk for the person administering the drug and the patient. This cracking has [...]

Vacuum Retention in Vial-Stopper Systems: A Study on Component Compatibility

Jeff Smythe, Lynn Lundy, and Amy Miller The pharmaceutical industry faces challenges when choosing packaging components for lyophilized products. The European Commission Guide to Good Manufacturing Practice, Annex 1, Section 89 states, “Containers sealed under vacuum should be tested for maintenance of that vacuum after an appropriate, pre-determined period.” Selecting optimal components for the lyophilization [...]

Validation of a Method to Determine Extractable Content in Polypropelene

Validation of a method for determination of extractable additives from a polypropylene material of known composition was performed.  A test method was developed based on results of studies outlined in a protocol written by the PQRI Leachable and Extractable Working Group titled “Experimental Protocol for Controlled Extraction Studies on Plastic Test Articles.”  The method quantitates [...]

Creating a Verification Process, not an Inspection Process

West’s Peg Frandolig, Technical Customer Support Manager, recently presented “Creating a Verification Process, not an Inspection Process” at the PDA 2011 Visual Inspection Forum, Oct 3-6, 2011. Good pharmaceutical practice requires the individual physical inspection of drug product container closure systems in order to reject those showing evidence of contamination with visible foreign material. Drug products in [...]

An Alternative to Current Sterilized Plungers for Glass Syringes

The use of steam has been the preferred technique to sterilize components for sterile parenteral applications.  Steam is the most common method of sterilization for vial stoppers and related components.  However, in the case of plungers for prefillable applications, gamma irradiation has been the historic standard throughout the industry for sterilization of the elastomeric components, [...]

Glass Flakes in Drug Product Trigger Massive Recall

The recently initiated voluntary recall of certain lots of anemia drugs was due to potential contamination of products with glass flakes.  Over 324,000 vials of drug product were recalled. The products are indicated for the treatment of anemia related to HIV therapy, chronic renal failure and chemotherapy.The glass flakes, also known as siliceous flakes, are [...]