FormaPharm Engineering Group attended the Pharmaceutical Compliance and Validation Training Course – CVS, held in Copenhagen, Denmark which covered a wide range of key compliance subject areas. Our goal is to improve our technical and regulatory knowledge in the subject area and become more familiar with current best industry practices.

Such courses help us to comply with pharmaceutical regulatory expectations and helps maximize the performance of our staff.

This course covers Isolator Technology and Restricted Access Barrier Systems (RABS) used in Aseptic Manufacturing. The choices of systems available and the advantages and disadvantages of using Isolators or RABS over traditional Aseptic Manufacturing, together with an overview of all key applicable guidelines, standards and regulations were considered. The course also covers design (types of systems, ergonomics, air classification and air-flow requirements) and the qualification/verification of the equipment systems involved, including facility and HVAC systems for Isolators/RABS and surrounding/supporting areas. Also included is the development, optimization and qualification of sanitization cycles, together with requirements for operation, maintenance, testing, inspection and monitoring of the systems and environments involved. The course was heavily orientated towards basing decisions for design, qualification/verification, operation and routine monitoring/testing/inspection on risk to product quality and ultimately risk to patient.

Upon completing this course FormaPharm Engineering Group has acquired a better understanding of the types of systems and options available for Aseptic Manufacturing; appreciates the pros / cons and applicability of the different types of systems; understands key considerations for the design, qualification / verification and operation / maintenance of RABS and Isolator systems; appreciates the different requirements for facility / HVAC systems in supporting areas; are able to apply and share their new knowledge; improve our individual effectiveness;