Repackaging Service

Repackaging service
in cleanroom

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.

What are the advantages?

  • Cleanroom Grade A/B – C
  • 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
  • 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

GMP Approach

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.

Repackaging service
in DPTE-BetaBag®

Pharmaclean® offers a customised third party repackaging service for pharmaceutical applications.

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.

What are the advantages?

  • fully validated and guaranteed transfer process
  • minimised transfer and handling
  • significantly reduced risk of biological and particulate contamination
  • optimised productivity
  • saved validation and cleaning time on site

What can you repackage?

  • caps
  • capsules
  • syringes
  • plastic bottles
  • Petri dishes
  • cleaning materials
  • monitoring devices
  • and much more…

Structure: cleanroom grade A/B – C

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.

  • operational flow in line
  • cutting machine and Industry 4.0 automated machines
  • pharmaceutical grade cleanroom finishing
  • automatic My&Clean system for gloved hand disinfection
  • MyPage+ for effective communication
  • pass box for production material outlet and pass box for process controls
  • colour-coded flooring for identification of production areas

Flexibility in quantities and deliveries

Pharmaclean® does not require minimum quantities and reduces delivery times.

Within the department there is a RABS dedicated to:

  • customised repackaging
  • packaging of raw materials to be transferred into isolators

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