AM Distribution

Staff is the main source of contamination in cleanroom.

AM offers a full range of disposable cleanroom garments, the optimal barrier between operator and classified environment. Excellent breathability, thermal and mechanical resistance, attention to comfort.

The purpose of cleanroom garments is:

• Protect the environment and the product from contamination brought in by the operator
• Protect the operator from hazards (chemical and biological) related to materials and products

Sterile and nonsterile disposable garments:

• masks
• overalls
• gowns and aprons
• socks and overshoes
• scafanders
• headphones
• sleeves

Gloves for cleanroom and laboratories, meeting the required regulatory requirements, with the dual function of protecting the operator and the product from the risk of contamination.

Available in different lengths and sizes to ensure protection, fit and comfort.

Available in different materials and thicknesses for specific applications and needs.

All gloves are classified as PPE according to current regulations and designed to ensure a controlled, contamination-free environment in the pharmaceutical, microelectronics and biotechnology industries.

Cleaning activities must be managed according to written and recorded procedures (SOPs) within a company-specific document system and must be performed by properly trained personnel.

AM cleaning equipment and related accessories meet all criteria required by current regulations:

• ergonomics (size, weight, shape)
• ease of cleaning
• resistance to chemicals used
• resistance to autoclave sterilization temperatures
• Low release of particles and chemical or microbiological contaminants
• compliance with current safety and environmental protection regulations
• availability of complete data sheets
• quality certificates attached to shipments and/or downloadable from restricted area

A complete series of biocides, filtered alcohols and steriles from the Ecolab line to reduce the risk of microbial contamination in cleanroom.

Produced in a contamination-controlled environment, they are supplied in different formats for the needs of cleanroom cleaning and disinfection activities.
Products are supported by complete documentation and certified. Dedicated team supports customers with advice on biocide rotation, specific uses, SOP.

Wide range of cleanroom stationery: writing, stickers and accessories.

Paper, notepads, pens and other cleanroom materials for recording and storing data and other information within controlled environments.
The materials used, in addition to being compatible with cleanroom needs, are designed to be more resistant to the tear and heat generated by copiers and printers.

A complete range of liquid and powder sampling systems, complying with FDA, EC 1935/2004 and EU 10/2011.

The choice of the most suitable sampler depends on multiple factors:

• the characteristics of the product to be sampled
• the type of sampling
• the container of the product to be sampled
• the frequency of sampling

AM offers single-use systems, which have the following advantages:

• no risk of cross-contamination
• no need for validation of the cleaning process
• Elimination of operator-generated contamination risks
• lightweight and easy to use
• cleanroom products
• also available in sterile version
• Elimination of contamination risks associated with the use of reusable samplers
• produced with FDA-accepted polymers

Swabs for all kinds of applications-from cleaning validation to precision cleaning to applying small amounts of solvents and solutions.

Swabs are available in different types of materials, sterile or nonsterile, and meet quality requirements:

• low particle release
• thermal welding
• cleanroom production
• high compatibility with disinfectants and detergents

Complete range of autoclavable stainless steel tools for specific cleanroom use. Screwdrivers, wrenches, pliers, and all tools needed for maintenance of classified areas.

Pharmaclean® products for sterilization and protection from particles and microorganisms offer total safety and durability, are customizable and easy to use.

Incorruptible after autoclave sterilization stage, they are not subject to breakage.
Accompanied by certificate of conformity and irradiation certificate where required.

Traceability of the batches produced is also maintained, enabling them to be traced back at all times to the documents related to them and to the end customer to whom they were delivered.

AM designs and manufactures technical cleanroom furniture that meets a wide range of operational needs by ensuring ergonomics, appropriate workflows, solid construction, practicality and safety.

• AISI 304 Ni-Cr 18/10 and AISI 316 stainless steel
• Scotch Brite exterior finish or high-gloss finish
• Rounded interior corners to prevent dust deposits and facilitate cleaning and decontamination
• Absence of sharp edges and dangerous spots

Solutions that can be customized and adapted to the cleanroom layout.
All furnishings are designed to simplify cleaning and decontamination operations, as well as minimize the impact on the dynamics of laminar flows within the environments.

Tear-off carpets and custom-made fixed flooring that can ensure total safety in contamination-controlled areas

Ideal for reducing the risk of contamination in entry/exit routes from critical areas, locker rooms, transfer areas, corridors and air locks.

BENEFITS

• Prevent 99% of vital and total contaminants from entering critical areas
• Reduce the level of contamination by particles or microbial agents on floors or suspended in the air
• Define a clearly visible barrier zone that signals personnel to enter the critical zone
• Keep shoes and wheels clean with improved electrostatic discharge
• Improve the quality of the work area due to less allergens in the atmosphere

Sterility test isolators: a complete line of integrated solutions for a fast and reliable process.

Getinge sterility test isolators shrink containment around the process separating it from the external source of contamination, providing a self-contained, safe and sterile environment for the most critical steps of the testing process.

The isolators can be configured according to specific space and workload requirements; the modularity of the systems makes relocation operations quick, easy, and safe

The integrated Steritrace II VHP system, common to all models, can provide a repeatable, validatable and fully traceable biodecontamination cycle.

Flexible or rigid wall isolators: modular installations that can be integrated with DPTE® transfer systems and control tests.

From the collaboration between AM and CSV Containment a line of containment products.

• Flexible insulators
• Continuos liner
• Separation and containment devices
• Iris Mouse Hole

APPLICATIONS

• containment applications up to EPO 5
• pilot projects or projects under development
• Adaptation of existing facilities for HP productions
• When implants through rigid containment systems cannot be used

BENEFITS

• cost reduction
• rapid development adjustment projects
• optimized ergonomics
• possibility of continuous implementation
• Safe, effective and operator-friendly use
• Reducing the risk of cross-contamination
• quick installation
• Smepac validation

As a global partner for the pharmaceutical industry, Getinge brings more than 100 years of experience in pharmaceutical production washing and sterilization to every project. Find out how Getinge can meet all your aseptic processing needs.

GMP WASHING SYSTEMS

Quality assurance, efficiency and safety in the process.
The washing process is part of GMP pharmaceutical production. Getinge Their versatility makes them suitable for both production applications and the most demanding requirements of laboratory processes.

LABORATORY GLASS CLEANER

Efficient and sustainable, Getinge glassware washing systems offer the solution for an
effective and repeatable cleaning of all types of laboratory glassware and objects compatible with automatic washing.
Glassware washers can be configured with a wide selection of trays and accessories. Specific cleaners complete the range.

Getinge 's terminal sterilization and logistics systems enable safe and efficient terminal sterilization of all types of packages: ampoules, syringes, cartridges, bags, BFS containers and more.

With Getinge's process development capabilities, we are able to support the latest, most complex and sophisticated drug delivery systems.

From the simplest handheld, HH3013, to the more sophisticated 100LPM SOLAIR 3350, Lighthouse products
offer quality construction and operational reliability.

The ELITE laser diode (Extreme Life Laser Diode Technology) with a life cycle of as much as 20 years proven by accelerated aging tests is installed on all models.
The entire range of equipment is protected by a two-year warranty and enjoys AM technical support.
Lighthouse particle counters come complete with LMS EXPRESS software: it is now possible to obtain reports for
validation according to ISO or EU GMP standards by simply downloading the data from the instrument or from USB flash drive.
The generated reports can be archived or printed.
LMS EXPRESS is software that operates in the CFR21 part 11 environment.

• particle counters in ultrapure liquids
• Airborne particle counters for cleanroom applications
• Photometers for performing HEPA/ULPA filter integrity tests
• Particle counters in ultra pure liquids for the electronics industry
• environmental microbiological samplers

ZHEROX® is the complete line for environmental and surface biodecontamination with innovative HPE technology.

Zherox® | Zherox® Light | Zherox® Fixed System | Zherox® b-pack | Zherox® pass-box with HPE technology

Technology

A solution of less than 8 percent hydrogen peroxide is diffused through a nozzle, creating a mist of micro-droplets that, passing through a high-voltage electromagnetic field, undergo an ionization process.
The resulting solution possesses a high concentration of hydroxyl radicals and reactive oxygen species (ROS) capable of damaging microorganisms through oxidation of proteins, carbohydrates and lipids.
The electromagnetic field imparts an electrostatic charge to the mist, which thereby acts as a gas due to the mutual repulsive activity of the positive charges.
The result is a high diffusion of the solution that is capable of reaching 100 percent of the treated area.
The resulting products, oxygen and water, leave no residue on surfaces. The Zherox® line ensures:

• Efficacia validated
• Excellent compatibility with all materials
• Innovative Technology
• Reduced cycle times
• Maximum automation
• Data Integrity

AM designs and manufactures laminar flows for contamination-controlled areas according to current ISO 14644-1 standards.

A team of qualified designers, technicians and operators assists customers from development through delivery and after-sales service.
Advanced technologies and design, space adaptability and operational excellence.
Sectors: pharmaceutical, chemical, electronics and food; in manufacturing and research processes.

• Laminar flow modules, which can be assembled according to variable sizes and geometries
• Down-crossing hoods traditional and new generation materials with HPE technology
• RABS
• Self-powered, battery-powered fluxgate trucks designed for transfers of containers with potentially exposed product between Grade A areas through lower-rated areas in complete safety
• Air showers
• Fluxed cabinets

Hand disinfection solutions: automatic systems, dispensers, liquid and gel products for cleansing and disinfection.

A good hand washing and disinfection program results in better hygiene, counteracts cross-contamination, and reduces health risks to operators in classified environments.

Design and implementation of particle and microbiological monitoring facilities and automation plants integrated with production lines, complying with cGMP, GAMP and ISO guidelines.

One dedicated team present from the design and implementation phase to the commercial phase, one contact person for all stages of the process.
In accordance with GAMP guidelines, our team proceeds according to a workflow adapted to the needs of the individual customer: from initial surveys, to system design and planning work, from the implementation of integrated software developed in harmony with the needs of the requesting company, to installation and testing, from validations to operator training. Our technicians can connect to the system from remote locations to provide real-time service and support. Immediate reporting can be accessed through a simple command.

Available in a variety of materials, low particle release, autoclavable or already sterile, dry and prepreg, in sizes suitable for both manual and brush use.

Use for cleanroom and laboratory cleaning in the pharmaceutical, biomedical, semiconductor, microelectronics, aerospace, health care, nutraceutical, and food industries.

Useful parameters in choosing cloth:

• degree of cleanliness required
• absorption capacity
• robustness
• possibility of autoclaving
• type of fabric
• chemical compatibility
• type of packaging
• simplicity of use

A complete set of sterile and nonsterile cleaners for cleaning in classified environments.

The new Annex 1 highlights the importance of a specific cleaning program, prior to the disinfection phase.

Cleaning is defined as the process of removing contamination such as residues from disinfectants and/or processing. For this purpose, the line of products provided by AM, provides a comprehensive program that contemplates the use of cleaners and disinfectants to reduce the risk of residues in the cleanroom.

Insulator gloves with excellent mechanical properties, resistance to breakage and abrasion, excellent permeability.

We offer a complete line of gloves and sleeves for isolators and RABS, available in different lengths, materials, diameters, thicknesses and sizes. We guarantee support in selecting the most appropriate product to ensure maximum protection and safety during critical activities in an aseptic environment.

The Pamas instrument line, a reference manufacturer of systems for particle counting in fluids, represents the
"state of the art" of this measurement technique, which is indispensable both for performing quality control tests in the
pharmaceuticals and for verifying the degree of contamination of fluids used in hydraulic circuits.

The management software, which is compatible with the most common reference standards such as ISO-NAS-SAE, allows you to
set up customized methods of analysis and perform in an automatic and guided way all the tests required by the
most widely used international pharmacopoeias.

• • Particle counters in liquids for pharmaceutical and hydraulic applications
  • Particle counters in drinking water

From the simplest handheld, HH3013, to the more sophisticated 100LPM SOLAIR 3350, Lighthouse products
offer quality construction and operational reliability.

The ELITE laser diode (Extreme Life Laser Diode Technology) with a life cycle of as much as 20 years proven by accelerated aging tests is installed on all models.
The entire range of equipment is protected by a two-year warranty and enjoys AM technical support.
Lighthouse particle counters come complete with LMS EXPRESS software: it is now possible to obtain reports for
validation according to ISO or EU GMP standards by simply downloading the data from the instrument or from USB flash drive.
The generated reports can be archived or printed.
LMS EXPRESS is software that operates in the CFR21 part 11 environment.

• particle counters in ultrapure liquids
• Airborne particle counters for cleanroom applications
• Photometers for performing HEPA/ULPA filter integrity tests
• Particle counters in ultra pure liquids for the electronics industry
• environmental microbiological samplers

A complete range of liquid and powder sampling systems, complying with FDA, EC 1935/2004 and EU 10/2011.

Sampling systems for powders, liquids and semi-solids are also available in 316L stainless steel and autoclavable plastic.

The quality of the autoclavable plastic, as well as the linearity of design of the steel systems-welds aimed at eliminating any gaps, mirror-polished finish, and absence of cracks-ensure full adherence to GMP guidelines.

A complete range of liquid and powder sampling systems, complying with FDA, EC 1935/2004 and EU 10/2011.

The choice of the most suitable sampler depends on multiple factors:

• the characteristics of the product to be sampled
• the type of sampling
• the container of the product to be sampled
• the frequency of sampling

AM offers single-use systems, which have the following advantages:

• no risk of cross-contamination
• no need for validation of the cleaning process
• Elimination of operator-generated contamination risks
• lightweight and easy to use
• cleanroom products
• also available in sterile version
• Elimination of contamination risks associated with the use of reusable samplers
• produced with FDA-accepted polymers

Tear-off carpets and custom-made fixed flooring that can ensure total safety in contamination-controlled areas

Ideal for reducing the risk of contamination in entry/exit routes from critical areas, locker rooms, transfer areas, corridors and air locks.

BENEFITS

• Prevent 99% of vital and total contaminants from entering critical areas
• Reduce the level of contamination by particles or microbial agents on floors or suspended in the air
• Define a clearly visible barrier zone that signals personnel to enter the critical zone
• Keep shoes and wheels clean with improved electrostatic discharge
• Improve the quality of the work area due to less allergens in the atmosphere

Pharmaclean® sterile stationery contemplates antibacterial pens and markers, notebook and notebook paper, and low particle release labels and tapes. Products can be supplied in VHP-resistant packaging for specific isolator applications.

The chairs and stools offered by AM, in addition to the necessary regulatory compliance features, have enormous advantages for the operator.

From the comfort of the seats, in varying sizes, to the materials used, to the compactness of the structure and the resulting ease of cleaning.

The chairs are made according to the latest ergonomic knowledge, comply with DIN 68877 and have the GS "safety testing" mark.

Chairs and stools are available in the following materials:

• stainless steel
• ESD artificial leather
• polyurethane

AM offers goggles and protective masks, disposable and autoclavable.

Anti-allergic materials, scratch-resistant lenses, anti-fog slits and high optical quality make the products ideal for comfort and quality.