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Pharmaceutical Manufacturing and Packing Sourcer

Outsourcing Stopper Preparation

The factors to consider when adding a barrier isolation unit to an existing manufacturing facility are of key concern to pharmaceutical manufacturers. After a complete analysis of requirements and resources, a manufacturer often discovers that establishing processes to prepare stoppers for the barrier isolator requires significant capital expense and may cause schedule delays. By working closely with the stopper manufacturer, the pharmaceutical company can expedite project completion times and provide added value to its process. Stoppers intended for use in barrier isolation units are designated as ready-to-use (RU). RU stoppers must be final rinsed in USP water for injection and must be terminally sterilised; they may also be siliconised if the pharmaceutical company chooses. The stoppers must be delivered in packaging that allows direct introduction into the sterile filling unit. Most important, the stopper manufacturer must control and validate the sterilisation process, bacterial endotoxins, particle and silicone levels to comply with recent US and European regulatory requirements.

Outsourcing - Arriving at the Decision

The decision to outsource any element of production must be based on validated financial and resource predictions. Valid reasons for outsourcing stopper preparation include improving the commercialisation timeline; establishing an effective, dedicated supplier team; freeing up financial, staff and facility resources that can be directed elsewhere within the company; and limiting capital spending. When a pharmaceutical company decides to change its manufacturing processes, it should consider only adding capabilities that are within its core competencies. The installation of a barrier isolation unit, a relatively new technology, could impose new stresses across multiple functions within the facility.


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By Robert Nase, Westar® Programme Director for West Pharmaceutical Services, and Douglas Stockdale, President and Chief Executive Officer of Stockdale Associates Inc

Robert Nase is Westar® Programme Director for West Pharmaceutical Services. He has held various positions in the quality assurance department at West, both in manufacturing and on a corporate level. Prior to joining West Pharmaceutical Services, he was employed by Johnson & Johnson for 11 years in the cardiovascular division, holding positions in quality assurance, microbiology and sterilisation technology. Mr Nase holds a BZ in Biology and Chemistry from Catawba College and is a member of ISPE and Association for the Advancement of Medical Instrumentation (AAMI). He has also served on the Health Industry Manufacturers Association Biological Support Committee for Microbiological Methods for Package Integrity.

Douglas Stockdale is the President and Chief Executive Officer of Stockdale Associates Inc, a lean manufacturing and validation/compliance consulting company for the life sciences industry. Prior to founding Stockdale Associates he gained 20 years' operational experience with Baxter Healthcare, and is an internationally known speaker, writer and advisor to the industry. Mr Stockdale is a member of the PDA & ISPE and sits on the Board of Directors for the Greater Los Angeles chapter of ISPE, chairing the Education Committee. He also holds an MBA from University of La Verne and a BS in Package Engineering from Michigan State University.


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Robert Nase
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Douglas Stockdale
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