Pharmaceutical Technology Europe - December 2010 - (Page 8)

Developing sterile packaging for aseptic environments Cleanliness is always concern number one when it comes to designing and manufacturing sterile packaging. Sterile packaging for product or filling components is typically much closer to the patient than other single-use containers. As such, there is virtually zero tolerance of particles and particularly bioburden; one eyelash that makes its way into a vial can cost millions of Euros in lost drug product, recalls and regulatory/legal costs. only ISO Class 7). Maintaining such stringent conditions can be a huge challenge, and requires a great deal of manufacturer “know how” and experience. “An interesting trend in recent years has been the growing use of barrier isolator technology.” An interesting trend in recent years has been the growing use of barrier isolator technology. As more processes are performed inside isolators, the cost and challenge of transferring sterile items into them has grown. The industry response has been a wholesale move away from reusable containers in favour of flexible single-use bags mated to isolator “beta ports”. This new technology allows clean, sterile components Richard Bhe lla Key industry trends The critical need for the cleanest possible packaging is driving leaders in this market to manufacture under near-sterile conditions; there is a growing consensus that the use of ISO Class 5 cleanroom conditions is imperative (by comparison, the norm for the rest of the single-use bag industry is like stoppers or syringe parts to be shipped to the point of use, sterilised if necessary, and then introduced to the isolator all in the same single-use bag. This capability can deliver a significant process efficiency boost for the end user. that need to be considered to ensure suitability for aseptic environments. Double-layer packaging of the product allows outer layers to be peeled away as the package is moved from a less clean “gray space” into the aseptic environment. In some cases, the outside of the package may need to be sanitised by bleach or alcohol wipedown, or even by VHP — obviously, the package should withstand this treatment without degradation. PTE Based on a contribution by Richard Bhella, Global Product Manager for Single-Use Storage & Delivery Technologies at ATMI. To read the full version of this article, go to www.pharmtech.com/rbhella www.atmi.com Ensuring full sterility Other than cleanliness and suitability for the chosen sterilisation method, there are a number of practicalities 1 CONTENTS 6 POST MONITORING 3 REGULATIONS REALISTIC? 8 STERILE PACKAGING 4 PASSING INSPECTIONS 10 CLEANROOM DOORS 5 SELECTING SOLUTIONS 11 TOP TECHNOLOGIES http://www.pharmtech.com/rbhella http://www.atmi.com

Table of Contents for the Digital Edition of Pharmaceutical Technology Europe - December 2010

Pharmaceutical Technology Europe - December 2010
Table of Contents
Pharmaceutical Technology Europe Poll Uncovers the Biggest Challenge to Implementing Cleanroom Conditions Amongst Readers
Are Cleanroom Regulations Realistic?
Passing Cleanroom Inspections
Selecting the Right Cleanroom Solutions
Defining the Right Cleanroom Post Monitoring Programme
Should You Implement Modular Cleanrooms?
Developing Sterile Packaging for Aseptic Environments
CMO Cleanroom Challenges
Choosing Your Cleanroom Door
Eight Top Cleanroom Technologies Showcased

Pharmaceutical Technology Europe - December 2010