Toxicological and clinical supplies of parenteral products are prepared in the Clinical Manufacturing Area (CMA), a unique aseptic fill / finish facility with containment capabilities. Products that can be safely processed with a high level of containment in this area include cytotoxic, biologicals, and highly potent compounds. The operation has successfully completed containment challenge studies conducted by Safebridge Associates, has been inspected and approved for handling Biological Safety Level 2 (BSL-2) material by a leading government body, and has been qualified for aseptic processing. Processing Suite 1 (PS1) within the clinical manufacturing area features HEPA unidirectional air supply to areas qualified as ISO 5, along with HEPA returns for containment. Soft walled isolators can also be installed within the PS1, fitted with HEPA supply and returns for compounding bulk solutions, filtration, filling, and lyophilizer loading and unloading operations when a high level of containment is required. Capping, inspection and bulk packaging provide comprehensive product preparation capabilities within a controlled environment.
Container sizes: From 2cc to 160cc presentations
Bulk solutions: High level aseptic containment to 15L and aseptic processing to 75L
Batch Sizes (Lyophilized): High level containment: 2 to 160cc presentations (1100 of 10cc vials)
Aseptic processing: 2cc to 160cc presentations (7000 of 10cc vials)
Equipment: Dedicated and disposable product contact Disposable isolators for high level containment
The layout of the CMA encompasses support operations for activities conducted in the Processing Suite. Manufacturing a variety of products in a wide range of container/closure configurations is achievable, enabling a unique flexibility in small scale manufacturing of parenteral products. The qualified facility and equipment provide personnel and product protection through maintaining an environment capable of high level containment with aseptic processing. Direct product contact surfaces are dedicated and disposable, including the containment isolator, mitigating cross contamination and assuring the highest level of safety, quality and purity for every batch.
Lyophilization Technology, Inc. 30 Indian Drive, Ivyland, PA 18974-1431 USA • +1 (215) 396-8373