COMMISSIONING: An Opportunity to Test, Challenge, and Improve the System Prior to Qualification

Commissioning gives biopharmaceutical companies the opportunity to work out the kinks in their equipment prior to qualification for GMP activities.  However, companies make the mistake of skipping the commissioning phase.  After vendor startup of equipment or after a minimum of air test and balance and room walkthroughs for a facility, companies head straight into qualification without analyzing true functionality, usability, …

Facility, Utility, and Equipment Qualification

When starting up a new manufacturing area, the qualification of systems that support the drug production process (facilities, utilities, and equipment) is essential to ensure patient safety and product quality, and to meet regulatory requirements and business needs.  Qualification must be done quickly and correctly so the area can be used for production. In the life science industry, missing one …

Aseptic Fill Lines

Purchasing an aseptic filling line can provide a huge economic advantage to a pharmaceutical company looking to increase its scale and throughput. An aseptic filling line can reliably increase production capacity, standardize quality, and reduce operator labor by combining multiple processes into an integrated system. Unfortunately, many companies don’t accurately estimate the level of effort needed to effectively engineer, procure, …