U.S. BioLife SciSafe Biostorage Facilities Receive CAP Accreditation
Image Credit: SciSafe
BioLife Solutions SciSafe Biostorage Facilities in the U.S. have been awarded the College of American Pathologists (CAP) Accreditation.
The CAP Accreditation Program is awarded to laboratories that meet requirements for accuracy, consistency, and quality in biostorage services.
All SciSafe BioStorage Centers of Excellence located in the U.S. have earned this certification.
Lab Design News spoke to Garrie Richardson, the founder and general manager of SciSafe about the certification, and BioLife Solutions.
Q: Could you please introduce yourself?
A: I head up SciSafe across all sites and am the founder of the business. With over 10 years of sample management experience, I have overseen the growth of SciSafe’s business from three chambers to hundreds today, with further plans for expansion. I have intimate hands-on experience with all aspects of sample management and maintain a focus on continuous improvement initiatives. I am also responsible for the strategic direction of the organization with a laser-focused goal of SciSafe becoming the global leader in Sample Management and Integrated Cold Chain.
Q: What is BioLife Solutions?
A: BioLife Solutions is a leading provider of class-defining bioproduction tools and services to the cell and gene therapy (CGT) and broader biopharma markets. Our tools facilitate basic and applied research and the commercialization of new therapies by supplying solutions that maintain the health and function of biologic source material and finished products during manufacturing, storage, and distribution.
SciSafe services range from hybrid-onsite sample management to complete customized outsourced biostorage solutions. As an established and experienced world leader in cGMP biological and pharmaceutical storage, our tailored approach to client challenges offers flexible, customer-first solutions.
Q: How does design/construction play a role in this certification?
Image Credit: SciSafe
A: Design and construction play a significant role in the College of American Pathologists (CAP) Biorepository accreditation process, as it is awarded to laboratories that comply with rigorous quality standards, which also apply to lab design. With this accreditation from CAP, biorepositories require specific planning so that the spaces are able to maintain exemplary biostorage services. Factors such as infrastructure redundancy and safety may be evaluated during the CAP accreditation process with on-site inspections and can impact the capabilities of the space. The physical layout of the biorepository must be designed to enable efficient workflow processes, segregation, and safety with adequate allocations for all necessary storage services. The design of the biorepository also needs to accommodate all necessary equipment and instrumentation.
Deficiencies in the design and construction of the biorepository can have an impact on the accreditation outcome, just as design and construction can have an impact on the quality of work completed. The physical environment, biorepository design, and biorepository construction all support the delivery of reliable and quality-driven processes.
