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AM Service
Our range
of services
From assistance to validation and process control; from on-site biodecontamination to repackaging for pharmaceutical applications, we offer safe and effective services.
AM also offers education and training services for operators in the pharmaceutical industry.
AM Service is available exclusively for the Italian market.
Environmental biodecontamination
An innovative on-site biodecontamination service with electromagnetized hydrogen peroxide-based HPE technology.
The biodecontaminating efficacy of the solution and its improved distribution are ensured by passing through an ionizing energy source consisting of an electromagnetic field that can increase the oxidizing efficacy of the solution by 50%.
- interventions that can be scheduled at night, weekends, and/or holidays so as not to interfere with normal production cycles
- Dedicated study of the area aimed at optimizing and customizing the biodecontamination process
- Preliminary inspection of the areas to be biodecontaminated carried out by our specialized technical team (upon request)
- Securing the areas to be treated and monitoring during the process steps
- Issuance of a technical report certifying each stage of the biodecontamination cycle performed
Repackaging in cleanroom
Repackaging service for pharmaceutical applications, including in DPTE-BetaBag® Getinge.
The Pharmaclean® team, operating in accordance with its Quality Management System, is able to provide full service consulting and management. Materials can be packaged in single, double and triple bags, in BetaBags for introduction into isolator or RABS, and sterilized by irradiation (gamma) by a qualified supplier.
What are the advantages?
- cleanroom Grade C Operational, RABS Grade A/B
- risk assessment
- Decontamination of materials performed with products specifically for use in cleanroom
- Finished product in single, double, triple-bagged, sterile or non-sterile according to requirements
- Sterilization of materials by irradiation performed at qualified suppliers
- Ability to validate the sterilization process according to ISO 11137 and 11737 and perform the sterility test according to EUPh 2.6.1
- identification and traceability of the entire process
- Service performed by highly qualified and continuously trained personnel
Validation
The group of technicians and specialists that make up the AM Instruments validation team can offer a wide range of services that include not only validations of HVAC and LAF systems but also those of autoclaves, furnaces, and depyrogenator tunnels.
Team activities include calibration and operational verification of critical instrumentation for demi, PW and WFI water generation plants.
Documentation
The drafting of DQ, IQ, OQ, PQ, FAT, SAT documents and protocols in accordance with industry regulations is carried out by experts whose task is to produce documentation in line with the requirements of national and international inspection authorities.
Assistance and Calibration
AM offers support and services among the most qualified in the market through its own multi-purpose laboratory equipped with work areas for instrument maintenance, repair and calibration.
Enter the restricted area and access the RMA service request form.
Our services contemplate assistance and calibration for:
- LIGHTHOUSE air particle counters
- PAMAS liquid particle counters
- AM is the only authorized laboratory in Italy to perform after-sales service for routine and extraordinary instrumentation maintenance
- Getinge Isolators
- AM being the sole importer for Italy of the Getinge brand is also the only company authorized to perform after-sales service for routine and extraordinary maintenance
- FOR AFTER-SALES SERVICE OF PRODUCTION EQUIPMENT AND INSTRUMENTS AM.
AM Campus Training
With AM Campus, we promote training and professional development in the field of contamination control, with a focus on operational issues and current regulations.
We believe in the personal and professional fulfillment of each and every employee, encourage participation in every company activity, recognize diversity, stimulate the spirit of belonging, and nurture every communication and training process that promotes individual and collective growth.
The AM Campus team is able to structure each training following the client's needs and their operator training requirements, devising specific programs for the requesting business landscape.
