Pharmaclean is the AM Instruments production dedicated to sterilisation and packaging in cleanroom

Published: 10-Nov-2022

Two Pharma-grade manufacturing sites, one comprehensive GMP answer

Covers & Sterility Protection Solutions

GRADE A/B-C CLEANROOM

Tyvek® covers and bags production repackaging service:

  • entirely made of DuPont™ Tyvek® material
  • standard and custom shapes and sizes
  • tear and perforation resistant
  • easy to apply and remove
  • low particulate release
  • excellent microbiological barrier
  • uniform vapour penetration across the surface
  • autoclavable
  • sterile version available

Sterilisation & Packaging Solutions

GRADE C OPERATIONAL CLEANROOM

Tyvek®-PET/PP bags and reels production

  • Industry 4.0 production machine with integrated Safe4Clean® material biodecontamination system
  • great peelability, very low particle release
  • raw material and finished product analysis
  • availability for production site audit
  • high efficacy antimicrobial barrier
  • excellent resistance to sterilisation cycles, rips and drillings
  • thumb notch opening and chevron welding
  • 5-year shelf-life
  • possibility to make drill to hang bag inside isolators
  • dedicated before- and after-sales assistance

CUSTOM MADE TO GMP

Being “custom made” means having a product specialist at your disposal, a thorough study of the problem and possible solution, a feasibility analysis and design based on your specific needs, and a final product aligned to Annex 1 requirements.

Pharmaclean® responds to the specific needs of the life sciences industry, producing customised protection, packaging and sterilisation systems. Each customer request is discussed with the support of our QA, defining the operational flows and any verification and release test, to offer a GMP-compliant service that satisfies customers’ specific requests.

You can request samples and quotes using the interactive form available on: global.aminstruments.com/am/mrq/

The form allows the customer to provide all relevant information to Pharmaclean® operators, in order to receive rapid and effective responses to requests for sample production and product quotes.

QUALITY CONTROL

Every phase of the process, from the acceptance of the raw materials to the release of the product, is rigorously controlled. AM Instruments conducts environmental and microbiological monitoring in all manufacturing areas in compliance with the standard UNI EN ISO 14644-1 and aligned with Annex 1.

CERTIFICATES

Each lot is delivered along with a certificate of conformity and an irradiation certificate, where applicable.

ON-SITE AUDIT

During audits, customers can verify compliance with our stringent quality specifications implemented in the production areas as well as in all processes. You can schedule an audit by sending a request to our quality department at siteaudit@aminstruments.com.

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