REPACKAGING SERVICE FOR PHARMACEUTICAL APPLICATIONS
When the materials needed for pharmaceutical production are not adequately packaged, the pharmaceutical customer needs to provide for 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 repackaging service operating in compliance with its Quality Management System
The Pharmaclean Quality Unit, in collaboration with the customer’s team, analyses the need, develops a SOP according to the GMP, stipulates a Quality Agreement to standardise the process and guarantee the quality requirements. All with particular attention to costs and delivery times.
ISO 5 and ISO 7 Cleanroom
decontamination of materials achieved with specific products for use in cleanrooms
finished product in single, double, triple pack, sterile or non-sterile according to the requests
materials can be packed into Getinge La Calhène Beta bags • custom sterile VHP packaging of tools (scissors, clamps, pens, filters, etc.) for use into isolators, RABS, pass-boxes
sterilisation of materials by irradiation performed by qualified suppliers supported by process validation according to ISO 11137 and 11737 if required. Execution of the sterility test according to EU Ph 2.6.1
identification and traceability of the whole process
customised lot identification per customer’s ERP/MRP systems
service performed by highly qualified and continuously trained personnel
customer’s total outsourcing of the repackaging process with the consequent capacity of focusing on core activities