GRADE A/B-C CLEANROOM
Tyvek® covers and bags production
repackaging service
A NEW ERA IS COMING!
Beyond the invisible
5
Beyond the invisible
Tyvek® covers and bags production
repackaging service
Tyvek®-PET/PP bags and reels production
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.
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.
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.
Each lot is delivered along with a certificate of conformity and an irradiation certificate, where applicable.
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.
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Since 1990 AM Instruments has been collaborating with international companies in the contamination control sector, with particular attention to the life science market.
In compliance with GMP guidelines, our Quality System ensures that all activities are carried out and managed according to high qualitative standards.
Innovation is the engine of our constant growth, which is achieved through the intuition and the expertise of our Research & Development Department.
A wide product portfolio meets the need of all of our customers, from cleaning equipments to biodecontamination machines.
AM Instruments offers fast and efficient services thanks to our trained professional technicians and to the use of high-tech machines
Thanks to an efficient and proactive team, AM Instruments offers a timely service aimed at meeting the needs of all our customers.