Pharmaclean® production for packaging and sterilisation

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 

Sterilisation & Packaging
Solutions

GRADE C OPERATIONAL CLEANROOM 

 

Tyvek®-PET/PP bags and reels production 

  • 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 

  • 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 

Pharmaclean® Tyvek® covers

Pharmaclean® Tyvek® bags

Pharmaclean® Tyvek®-PET/PP bags

Pharmaclean® Tyvek®-PET/PP reels

PRODUCTS AND PROCESSES ALIGNED TO THE NEW ANNEX 1

QUALITY CONTROL

Every phase of the process, from the acceptance of the raw materials to the release of the product, is rigorously controlled. We conduct 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, our 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. 

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.

SAFE4CLEAN®

Raw materials are biodecontaminated using our proprietary Safe4Clean® system. This allows a high reduction of viable and non-viable particles and ensures an excellent quality of the finished product. Process validation was performed by verifying the microbiological contamination of the raw materials before and after decontamination treatment and by particle counting in the vicinity of the system. 

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6 Reasons to choose AM Instruments

1

Expertise

Since 1990 AM Instruments has been collaborating with international companies in the contamination control sector, with particular attention to the life science market.

2

Quality

In compliance with GMP guidelines, our Quality System ensures that all activities are carried out and managed according to high qualitative standards.

3

Research & Development

Innovation is the engine of our constant growth, which is achieved through the intuition and the expertise of our Research & Development Department.

4

Products

A wide product portfolio meets the need of all of our customers, from cleaning equipments to biodecontamination machines.

5

Services

AM Instruments offers fast and efficient services thanks to our trained professional technicians and to the use of high-tech machines

6

Customer Care

Thanks to an efficient and proactive team, AM Instruments offers a timely service aimed at meeting the needs of all our customers.