Process & Cleaning Validation

MEDVACON's team partnered with a pharmaceutical client to the process and cleaning validation group and facilitate site-wide process and cleaning validation activities.Additional MEDACON experts joined the efforts to support several process and cleaning projects. The MEDVACON team developed the process and cleaning validation protocols and coordinated with manufacturing and quality personnel to pull and analyze validation samples and cleaning swabs.

MEDVACON went  onsite to troubleshoot a contract clients pharmaceutical process producing unwanted particulates in an aseptic process.  MEDVACON identified the identified the process defect and developed a technical report with a solution.  The fix was implemented and production resumed to mitigate costly rejected batches and production delays. 

MEDVACON joined a biopharmaceutical company creating novel therapies by applying deuterium chemistry to known molecules. MEDVACON led the process validation processes focused on our contract manufacturer drive for improved safety and efficacy. MEDVACON reviewed the process validation protocols and oversaw the entire validation process to ensure compliance with these product efforts receiving FDA approval. MEDVACON remains a continued trusted partner providing our client CMC and clinical supply support. 

MEDVACON collaborated with our medical device client to provide technical and regulatory evaluation following a facility fire contained to the medical device manufacturing area for multiple clients. MEDVACON provided remediation plan quidance and assisted in developing customer-specific cleaning and component disposition. MEDVACON provided medical device compliance expertise and a comprehensive company cleaning validation plan.