When the materials needed for pharmaceutical production are not adequately packaged, the pharmaceutical customer must carry out decontamination and repackaging to make them suitable for use in sterile environments and contamination controlled areas. The Pharmaclean team can provide advice and complete management of the packaging service, which complies with its Quality Management System.
The Pharmaclean Quality Unit, in collaboration with the customer’s team, analyses the need, develops an SOP that complies with GMP, and stipulates a Quality Agreement to standardise the process and guarantee the quality requirements. All with a particular focus on costs and delivery times.
Advantages of using Pharmaclean
- Grade A/B - C cleanroom
- GMP compliance
- Risk assessment
- Decontamination of materials achieved with specific products for use in cleanrooms
- Finished products in single, double or triple packaging, sterile or non-sterile, upon request
- Materials can be packed in Getinge La Calhène Beta bags
- Custom sterile VHP packaging of tools (scissors, clamps, pens, filters, etc.) for use in isolators, RABS, pass- boxes
- Sterilisation of materials by irradiation performed by qualified suppliers, with the option of process validation in accordance with ISO 11137 and 11737 if required. Sterility test performed in accordance with EU Ph 2.6.1
- Identification and traceability of the whole process
- Customised lot identification as per the customer’s ERP/MRP systems
- Service performed by highly qualified and continuously trained personnel
- The repackaging process is fully outsourced by the customers, allowing them to focus on their core business activities
