Facility
Controlled environments. Documented flow.
Processing, quality, packaging and storage operations organized around process control, material movement, documentation and traceability.
Inside the Facility
Cleanrooms
Controlled environments supporting tissue-processing operations.
Processing Suites
Work areas configured around process and material-flow requirements.
Quality Laboratory
Space supporting testing, inspection and documentation review.
Storage
Controlled storage aligned to product handling requirements.
Packaging
Primary and secondary packaging and labeling operations.
Equipment & Personnel
Qualified equipment operated by trained, documented personnel.
Facility Review
Evaluate the facility in context.
Facility capability cannot be reduced to square footage or room count. The relevant question is whether the environment, material flow, equipment, documentation, staffing and quality controls fit a defined program.
Program Fit
Tissue type, process steps, equipment and scale are reviewed together.
Controlled Flow
Material movement, processing, packaging, storage and records are considered as one operating system.
Qualified Review
Facility information is shared with qualified partners at the appropriate stage of program evaluation.
Specific classifications, capacities, licenses and facility metrics are shared only when verified and relevant to a program.