Case Study

R&D Pilot Plant Aseptic Isolator Vial and Syringe Filling

Project Snapshot

Aseptic filling of sterile drugs, also known as sterile filling, remains one of the most critical processes in biopharmaceutical manufacturing. Aseptic filling is an aseptic process that requires the close coordination and complex interaction between personnel, sterilized product, the fill/finish equipment system, cleanroom, isolators and support facilities, and sterilized filling components.

A leading Pharmaceutical company contracted Sterling Engineering to develop the basis of design, URS (User Requirement Specifications) and equipment selection for their Research & Development Aseptic Pilot Plant. The R&D Pilot Plant space was in a two-floor expansion to the existing manufacturing facility.
The Aseptic Pilot Plant equipment totaled over $15 million.
URS’s were developed for the isolators, lyophilizer, vial filling module, syringe filling module, solution compounding tanks, temperature control skid and other support equipment.
Because of the Sterling’s aseptic processing expertise, Sterling was able to work with the R&D Scientists, Engineering, Operations, and Aseptic Equipment Vendors to develop a process design and equipment selection.
Several vendors were solicited for design concepts for each piece of equipment. These concepts were extensively reviewed with the key stakeholders for the basis of design.
Sterling, as part of their on-going experienced engineering support team, worked with equipment vendors to complete the design and the FDA documents required for the project.

We used Sterling Engineering for several large strategic projects at plants across the country and I’ve been very pleased with their support. Their responsiveness to the demands of both internal and external stakeholders, their flexibility to changing priorities and scope of work, and their cross functional team approach contributed to project success.

R&D Pilot Plant Customer

Project Challenges

Unlike terminal sterilized filled drugs, the stability of the aseptic filled drugs is negatively affected by steam autoclave, dry heat ovens, Ethylene Oxide, and irradiation, either Cobalt 60 Gamma or E Beam. Thus, the need to utilize an aseptic process to fill certain biologicals, pharmaceuticals and biotechnology drugs.
This is due to its highly technique driven processes and the potential safety impact to the end user. There are only indirect safeguards for the sterility of the filled drug after it is stoppered and capped in the isolator.
The client did not have aseptic processing expertise or resources to undertake the project on their own.
Prior to this project the company had no Pilot Plant, so the scale-up of new products/processes were developed on small tabletop scale equipment. This small-scale process was then transferred directly on to the large-scale production equipment causing scale-up delays and using valuable production equipment time.
The client increased productivity with Sterling Engineering, a SME (Subject Matter Expert), as opposed to incurring the additional cost of bringing on a full-time employee or utilizing costly resources with their A & E firm.

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