In cases where the materials necessary for pharmaceutical production are not properly packaged, the pharmaceutical customer needs to provide for decontamination and repackaging to make them suitable for use in sterile environments and controlled contamination environments. The Pharmaclean team, operating in compliance with its Quality Management System, is able to provide advice and complete management of the repackaging service.
The Quality Unit Pharmaclean, in collaboration with the customer’s team, analyzes the need, develops a SOP according to the GMP, stipulates a Quality Agreement in order to standardize the process and guarantee quality requirements. All with particular attention to service costs and delivery times.
- ISO 5 and ISO 7 Cleanroom
- GMP compliance
- risk assessment
- decontamination of materials performed with specific products for use in cleanrooms
- finished product in single, double, triple pack, sterile or nonsterile depending on the requests
- possibility of packaging materials in Beta bags Getinge La Calhène
- packaging of materials (scissors, clamps, pens, filters etc.) for VHP biodecontaminated isolators (sterility testing or production) or pass-boxes, provided with VHP resistant foil bag, external LDPE bag and with irradiated final packaging
- sterilisation of materials by irradiation performed by qualified suppliers with possibility of process validation according to ISO 11137 and 11737 and execution of the sterility test according to EUPh 2.6.1
- identification and traceability of the whole process
- customised lot identification in accordance with the customer’s ERP / MRP systems
- service performed by highly qualified and constantly trained personnel
- total outsourcing of the rewrapping process by the customer with the consequent possibility of focusing the activities on its core business