Production
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Pharmaclean® stands out for its ability to offer tailored solutions that optimize efficiency, reduce risk, and ensure maximum compliance of operations in protected environments, where even the invisible detail makes a difference.
Production sites in Italy specialize in the manufacture of items made of Tyvek®, designed for packaging, sterilization and material transfer processes in contamination-controlled environments.
The production, featuring the proprietary Safe4Clean® for decontamination of raw materials at the entrance of the production cycle, takes place in Grade C Operational environments and complies with the quality standards required by Annex 1 and GMP.
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Production in Grade C Operational cleanroom
In our production units, each processing step, from the entry of raw materials to the release of the finished product, is tracked and documented in dedicated batch records. The contamination-controlled environment is subject to particle and microbiological monitoring according to the specific internal procedure and in compliance with UNI EN ISO 14644-1 and Annex 1. Each batch produced is released through approval by theQA unit with simultaneous issuance of a certificate of compliance and irradiation, where applicable.
Customization of solutions
With in-depth knowledge of production processes and specific customer needs, with a special focus on Contamination Control Strategy (CCS) and risk analysis, we also develop a comprehensive pathway by implementing customized solutions.
Each customer request is discussed with the support of our QA, defining operational flows and possible verification and release testing in order to offer a GMP compliant service. Our product specialists perform feasibility studies, which are followed by sample production, efficacy testing, and release of the finished product.
The goal is not only to improve safety and efficiency, but also to turn packaging into a strategic pillar for the success of the entire production process, which is not just designed, but must be validated, nurtured, and maintained over time.
The new Pharmaclean® envelope, 100% aligned with Annex 1 requirements.
The new Tyvek®-PET/PP pouch not only fully meets the requirements of Annex 1, but elevates them to a higher level. In addition to ensuring contamination control and compliance, this pouch introduces a unique innovation in pharmaceutical packaging. The process indicator, printed with validated technology, ensures theabsence of chemical residues during autoclaving and immediate verification of the outcome of the process. Lot number and product code printing enables full traceability and reduces the risk of cross-contamination, optimizing post-sterilization product management.
Selected and clean raw materials
Pharmaclean® uses excellent raw materials and, to ensure that the finished product fully meets regulatory requirements, uses the proprietary Safe4Clean® system to decontaminate raw materials before they enter the production cycle.
Safe4Clean® reduces contamination of viable and total particles by more than 60 percent on Tyvek® and 40 percent on PET/PP.
Pharmaclean® Products
bags and rolls made of Tyvek® - PET/PP poly-coupled material
The strength and breathability qualities of Tyvek® 1073B, combined with the transparency of PET/PP, allow the sterilized contents to be stored while maintaining total visibility.
Tyvek® covers and bags
They offer total safety and resilience, are customizable and easy to use. They ensure full adherence to the regulatory requirements of the new Annex 1.
Products for specific applications
Tray-Cover made of LDPE to contain the product throughout the bulk freeze-drying process: double-welded corners allow the cover to adhere perfectly to the tray.
Tear-resistant Tyvek® sheets with antistatic coating for separating and protecting wafers in the semiconductor industry. Low particle release to avoid particles and scratches.
Repackaging for pharmaceutical applications
In accordance with GMP, Pharmaclean® offre repackaging service for pharmaceutical applications and repackaging service in DPTE-BetaBag® for applications in isolators and RABS.
Quality control
Every stage of processing, from raw material entry to product release, is strictly controlled, and every workspace is subject to environmental and microbiological monitoring.
Certificates
Each batch is accompanied by environmental and microbiological monitoring reports, certificate of compliance and, if performed, irradiation.
On-site audits
An audit can be scheduled by sending a request to our quality department at siteaudit@aminstruments.com. During an audit, our customers have the opportunity to verify compliance with increasingly stringent quality and safety requirements related to the production site as well as processes.
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