Pharmaceutical Technologist - September 2007 - (Page 30)

Q&A // *Ken Frank Disposable income Pharmaceutical Technologist spoke to Ken Frank, president of Pall BioPharmaceuticals about the benefits of biodisposables and the role the Bioprocess Systems Alliance plays in promoting good practices. The role of biodisposables in biomanufacturing has become increasingly important. When did this trend begin? Single-use technologies have been around for many years. The first capsules for sterile filtration applications were developed more than 20 years ago. However, about 10 years ago, the introduction of flexible presterilized storage bags and bioprocessing containers in tissue culture media and buffer storage accelerated the trend towards single-use processing. What are the benefits of single-use technologies? Conventional stainless steel systems need to be sterilized before use and cleaned afterwards. Both operations require validation stages, which consume time and money. Single-use systems are significantly less expensive than stainless steel systems because the installation and validation costs are much less. They also eliminate cross-batch contamination and are more flexible in terms of switching from one product to another. For example, when producing clinical trials materials in contract manufacturing or multiproduct facilities, there is no need to validate that the cleaning process removes all traces of the previous drug. This means it takes much less time to get a new facility up and running and to switch from one product to another in a multipurpose facility. Are there any popular misconceptions surrounding biodisposables that prevent companies from adopting them? The issues that initially slowed down the adoption of this approach by some companies were uncertainties regarding the qualification of new extractables and leachables. Although leachables from metal containers may be problematic for some products, stainless steel systems are generally considered ‘inert’. Conversion to single-use plastic equipment does contribute to some low levels of leachables that must be qualified. Few companies want to be the first to adopt a new technology and incur the increased regulatory attention it brings, particularly where there is no established ‘best practice’. Additionally, many validation issues that were previously “uncertain” are now better understood. For example, potential leachables from sterilizing membrane filter cartridges were a topic of concern 15 years ago because of increased scrutiny by agency reviewers. This concern was addressed by manufacturers — to the satisfaction of regulators and users — by providing more extensive data on the characterization of such compounds. Comparable data for sterilizing membrane filters and flexible polymeric biocontainers (bags) were not generally available when these-single use technologies were first introduced, but are now provided by several suppliers. Not all component suppliers provide such data. It then falls to the system integrator to provide comprehensive extractables data for assembled single-use systems. The increasing number of unit operations available in economic single-use formats has helped fuel the adoption of this technology. Filter capsules were the first single use technologies to be widely used, but were previously only available in sizes suitable for processing small batches. Today, capsules are available to process even the largest production-scale batches. The use of bioprocess containers was also inhibited by size limitations, but these are now available in sizes up to 2000 L. 30 September 2007 l pharmaceutical technologist

Table of Contents Feed for the Digital Edition of Pharmaceutical Technologist - September 2007

Contents Editor’s Comment News Morpheus Market Watch CPhI Worldwide 2007 Compliant Pharmaceutical Labelling Q&A

Pharmaceutical Technologist - September 2007

For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.