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.
The Pharmaclean® team, working in accordance with its Quality Management System, is able to provide full management of the repackaging service.
Quality Assurance, in collaboration with the customer’s team, analyses the need and the process/service required by the customer, verifies the feasibility of the service through risk analysis, prepares the documentation according to GMP guidelines and guarantees the quality of the service through a dedicated quality agreement. All this with particular attention to costs and delivery times.
The repackaging service is carried out in a classified environment by qualified personnel in accordance with procedures and operating instructions agreed with the customer and GMP guidelines.
The Pharmaclean® area occupies 600 m2 within the AM Instruments site.
The site includes offices, production, primary and secondary packaging, Pharmaclean® quality control laboratory, a 350 m2 Grade A/C operational cleanroom and a 200 m2 area for secondary packaging.
Within the department there is a RABS dedicated to: