Plus Group provided services to a new aseptic filling line for a major biopharmaceutical company

The client facility includes sterile bulk manufacturing, aseptic filling operations, pilot plants, quality control laboratories, warehousing, and administrative offices in a 228,000 sq. ft. facility.  The requirement for a new filling line contributed to business growth and continuity of product supply by providing a second sterile fill line for powder-filled vials.  The Plus Group Validation Department has experience with the client’s approach to protocol development, review, approval, and execution.  The relationship built gaining this experience resulted in Plus Group Validation Specialists providing Commissioning and Qualifications (C&Q) services for the new aseptic filling line and the supporting utility systems.

Value Provided:

  • Plus Group leveraged an excellent working relationship to provide industry guidance and assist the client with an improved approach to GMP compliance.
  • Plus Group team assisted the client in developing efficient templates for compliance to corporate SOPs.
  • Plus Group Validation Specialists executed the project effectively meeting milestones on schedule due to site knowledge and an understanding of the process and the equipment.