Pharmaceutical Technology Europe - December 2010 - (Page 3)

Are cleanroom regulations realistic? The current expectations for cleanroom operations are those found in the FDA’s 2004 Guideline on Sterile Drug Products Manufactured by Aseptic Processing and EMA’s Annex 1: Sterile Medicinal Products. These documents are reasonably well harmonised with respect to environmental monitoring expectations, media fill requirements and other areas, but they differ with respect to classification of the core aseptic processing environments. With respect to environmental monitoring, both agencies do not consider the realities of aseptic processing and as a consequence, they over-emphasise environmental monitoring. There are several aspects that the regulators seem to ignore: • Aseptic processing is not ‘sterile’ processing; those terms don’t mean the same thing. The environments have never been, nor do they need to be ‘sterile’. • Methods to precisely measure the microbial level in the air or on a surface do not exist. This is particularly true in the cleanest environments. • You cannot sample your way to ‘sterility’ in a processing environment. Even the most aggressive sampling schemes fall way short and increase risk more than any insight gained. • Sampling is an intervention and subject to adventitious contamination. • There have always been (and always will be) viable but non-culturable species, we cannot detect everything, but then again we shouldn’t have to. Expectations for perfection in performance may seem reasonable considering the label claim, but is quite unrealistic and un-provable from a scientific perspective. such time as we have a universally accepted non-destructive sterility test for products, there is simply no means to assure sterility. I’ve always been a minimalist with respect to the need for regulation, and I also believe that all regulation should be based strictly upon science and should be vetted through a rigorous peer review process. I respect that we must have regulations, but I find they are often out-of-date before they are even published. PTE Jim Agalloc o Can sterility ever be completely assured? Sterility can never be guaranteed, and this represents a major technical disconnect between current regulatory policy and scientific reality. The sterility test as we know it today dates to the 1930s when processes were markedly less capable. In today’s aseptic processing, its utility is highly questionable. The sampling limitations are well documented and, unfortunately, unfixable. Until Based on a contribution by Jim Agalloco, President of Agalloco & Associates (USA). For the full version of this article, go to www.pharmtech.com/agalloco www.agalloco.com 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/agalloco http://www.agalloco.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