REPACKAGING FOR PHARMACEUTICAL APPLICATIONS
When materials needed for pharmaceutical production are not adequately packaged, the pharmaceutical customer needs to carry out decontamination and repackaging to make them suitable for use in sterile environments and contamination-controlled areas.
PHARMACLEAN® OFFERS CUSTOMIZED THIRD-PARTY REPACKAGING SERVICES THESE SERVICES ARE CARRIED OUT IN A CLASSIFIED ENVIRONMENT BY QUALIFIED PERSONNEL, IN COMPLIANCE WITH THE OPERATING PROCEDURES AGREED UPON WITH THE CUSTOMER AND WITH GMP GUIDELINES
The Pharmaclean® team, operating in compliance with its Quality Management System, can provide advice and complete management of the repackaging service.
The Quality Assurance unit works with the customer’s team to analyze the need, develop an SOP according to GMP, and draw up a Quality Agreement to guarantee that quality requirements are met, paying particular attention to service costs and delivery times.
WHAT WE OFFER
- grade A/B – C cleanroom
- GMP approach
- risk assessment
- decontamination of materials carried out with products specifically for use in cleanrooms
- finished product in single, double or triple packaging, sterile or non-sterile, depending on the request
- packaging of components in Getinge La Calhène Beta bags
- sterilization of materials by irradiation performed by qualified suppliers, with the option of process validation following ISO 11137 and 11737 and the performance of the sterility test as per EU Ph 2.6.1
- identification and traceability of the whole process
- customized lot identification in compliance with the customer’s ERP/MRP systems
- service performed by highly qualified and continuously trained personnel
- repackaging process fully outsourced by the customer, allowing them to focus on their core business activities