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The commitment to quality is a cornerstone of the italian company since from the beginning in 1990. A unique GMP Oriented program has started in 2015, aimed at aligning processes, productions, and more generally product and service offerings with the specific needs of the Life Science market. In just a few years, the company has reached the level GMP Consistent, having in common with customers not only operational methods but also objectives and results. The last few months have been largely dedicated to giving constant advisory support for the major challenges: from continuous microbiological monitoring to autoclave sterilization processes, from the transfer of materials to the new demands for bio-decontamination.

Sensitive operations are executed in cleanroom: this makes AM Instruments a partner in the manufacturing supply chain and an appreciated partner for consultation. Expertise combined with execution through the organization is essential for solving problems in pharmaceutical productions.

In the early 1990s, AM Instruments started producing monitoring equipment and laminar flow systems. Over the years, two distinctive product lines emerged: AMTech® and Pharmaclean®.

Both meet specific needs of the life science sector: Pharmaclean® means consumables dedicated to controlled environments, produced in constantly monitored GMP cleanrooms, such as packaging material for autoclave sterilization processes.

They cover a fundamental need that is the cornerstone of the new Annex 1- the implementation of a contamination control strategy based on risk analysis.

The packaging still widely used is made of medical paper, a material that the new Annex 1 criticizes for its low strength and high particulate release. Pharmaclean® offers packaging solutions made of Tyvek®, aligned with the regulatory requirements. Customized quality packaging facilitates operations and safes resources while maintaining process effectiveness and safety. Pharmaclean® product specialists inspect cases on field and carry out feasibility studies. Tests on dedicated samples with qualification and validation process finally approve the solution where the customer is supported through all stages. The high engagement in service and customer care is recognized and elevates the company to a partner level. 

The unique proposal of AMTech® is system integration, offering interconnected systems with a high level of automation.
Over the years, this technology hub has shaped an R&D department that boasts 5 patents to complete the portfolio with the main technologies for contamination control. Further to this, AMTech® is developing monitoring systems and engineering customized laminar flow systems, integrable with on-board monitoring and bio-decontamination systems.

The latest news is the Zherox® bio-decontamination line. It consists of mobile and fixed systems for environmental decontamination, with HPE technology based on a reduced concentration of electro magnetized hydrogen peroxide. The Zherox® b-pack portable devices instead enable surface decontamination, acceding most difficult points.
The patented line ensures effective and fast cycles, but most importantly, thanks to the variety of models, it meets the needs of bio-decontamination in areas of different sizes and ensures that even the most difficult spots in controlled environments are reached. Let's delve into the topic of the challenges of Annex 1. 

From a process perspective, AM Instruments has focused on the most challenging activities involving continuous microbiological monitoring, autoclave sterilization, and material transfer. A training event has supported customers in both theoretical and practical terms with continuous monitoring and issues related to frequency, plate placement, and innovative technologies that can support the activity, also with
the contributions of Dr.Tim Sandle, a world-renowned microbiologist.

For autoclave sterilization process, the expertise is shared during important events (SCC events, PDAs, Lounges etc.) and visits to production sites initiate the above-described process.

On material transfer, several facilities revamping projects have started, evidencing the need for pass-boxes with on-board bio-decontamination, as well as the transfer of materials by laminar airflow trolleys with continuous monitoring of viable and non-viable particles. MyBox® and Cart2Count® have also met these needs by creating facilities with dedicated layouts.