Sterility Test Facility Feasibility Study

Burns & McDonnell developed a preliminary scope and cost estimate to construct a sterility test laboratory within an existing pharmaceutical production facility. The laboratory will handle both liquid and solid media samples to determine sterility of the packaged product. The preliminary design and cost estimate focused on reducing cost and minimizing existing facility downtime during construction.

• Sterility laboratory design
• Construction cost estimate
• Evaluation of alternatives

Sterility of media testing products presents a significant challenge. The possibility of media contamination during handling and testing can create false positives, which require retesting, render the product unusable without further processing or lead to destruction of the product. Current operations are configured for operators to work within breathing air hoods and handle product under laminar flow during testing, but do not provide a classified background for sample handling. 

In an attempt to improve the reliability and efficiency of this area, the client wishes to explore the design and construction of a class 100 space for media testing, complete with gowning, airlocks, and material handling and testing equipment.

The proposed sterility test laboratory will be configured to handle media samples and will allow testing of containers ranging from 100 milliliters to 1 liter as well as 30 liter carboys. Material handling will be segregated by container size, and a single work station will accommodate the carboys.

Testing involves sterile filtration of media samples, filter collection, placement in sealed sterile containers and incubation. All waste will be immediately removed from the laminar flow work zone and placed in sealed waste receptacles. Waste will be removed from the space on a regular basis.  

To ensure adequate sanitation of the sample container exteriors and to prevent microbial exposure within the laboratory environment, loading of the samples into the work area where preparation and open handling occurs must be carefully controlled. Sterility testing is typically conducted in a class 100 environment having low to zero viable counts. Creating this type of space requires the proper blend of engineering and architecture to design an area that facilitates sanitation, organizes the work such that operators do not contaminate samples and incorporates utilities and airflow capable of maintaining the environment.

Laboratory organization will promote unidirectional flow of materials to reduce cross contamination. The design will include separate areas for incoming and outgoing materials and independent airlocks for materials and personnel. 

The 280-square-foot laboratory will include a 9-foot ceiling to allow for equipment installation and approximately 20 feet of bench space separated into three working zones. One zone will feature lower countertops to allow for manipulation and sampling of larger containers. To reduce cleaning requirements, work surfaces will exclude storage, and their design will promote the laminar air flow required for this type of testing. Exposed product work will not be conducted within 6 inches of the work surface or outside the laminar flow work zone.

• Designed class 100 (ISO 5) clean room with laminar air flow
• Performed architectural design of clean room
• Evaluated isolators and laminar air flow hoods against the clean room design to determine optimal sterility testing environment
• Provided cost analysis for capital project request