Two Pharma-grade manufacturing sites, one comprehensive GMP answer
Covers & Sterility Protection Solutions
Tyvek® covers and bags production repackaging service:
Sterilisation & Packaging Solutions
Tyvek®-PET/PP bags and reels production
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. 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.
Each lot is delivered along with a certificate of conformity and an irradiation certificate, where applicable.
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 email@example.com.