The Challenge Faced
- Development of the cleaning validation program for new clinical manufacturing site (Large Biopharma Company)
- No Cleaning methods in place
- Lack of approved analytical labs
- Deficient recovery swabbing methods
- High potency (category 4) oncology compounds
- Developed cleaning methods, cleaning study, cleaning validation and cleaning verification for OSD process equipment
- Developed sampling methods for OSD equipment (roller compactor, spray dryer and high shear wet granulator)
- Developed recovery swabbing method
- Created 12 operational and cleaning SOPs
- Created cleaning validation master plan
- Reduced the number of cleaning agents used from 12 to 4
In an age that demands a new level of compliance and regulatory adherence, our alliance of cleaning validation engineers are at the forefront of providing expert solutions. From the initial creation of cleaning studies, all the way through to cleaning monitoring reports, our team utilizes a risk-based approach that will allow for seamless solutions focused on regulatory compliance. Our SMEs also provide expert guidance when in need of remediation concerning your cleaning validation program.
Our leadership team has placed a special focus on cleaning validation and has assembled a team of SMEs that specializes in the full spectrum of equipment process train determination. PharmAllies’ alliance of experts has the knowledge base to assist you and your team in the planning and implementation or remediation of your cleaning validation program.