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Disposable garments made of lightweight materials of the highest quality-the excellent combination of comfort and safety.
Gloves suitable for all work environments and different applications, complying with regulatory requirements.
Disposable and autoclavable goggles and masks. Quality, ergonomics and comfort.
Getinge isolators are the answer to everyday needs in aseptic productions and microbiological laboratories: sterility testing, aseptic filling, medical device assembly, cell culture and therapy.
Washing systems for production applications that to the most demanding requirements of laboratory processes.
Safe and efficient terminal sterilization of all types of packages.
From the simplest handheld, HH3013, to the more sophisticated 100LPM SOLAIR 3350, Lighthouse products offer quality construction and operational reliability.
The Pamas instrument line, a reference manufacturer of systems for particle counting in fluids, represents the "state of the art" in this measurement technique.
A complete range of sampling systems for liquids, powders and granules, compliant with FDA, EC 1935/2004 and EU 10/2011, capable of reducing the risk of cross-contamination.
A complete range of sampling systems for liquids, powders and granules, compliant with FDA, EC 1935/2004 and EU 10/2011, in autoclavable plastic and stainless steel.
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:
Sterile and nonsterile disposable garments:
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.
AM cleaning equipment and related accessories meet all criteria required by current regulations:
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.
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.
The choice of the most suitable sampler depends on multiple factors:
AM offers single-use systems, which have the following advantages:
Swabs are available in different types of materials, sterile or nonsterile, and meet quality requirements:
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.
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.
Ideal for reducing the risk of contamination in entry/exit routes from critical areas, locker rooms, transfer areas, corridors and air locks.
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.
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.
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.
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.
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.
Zherox® | Zherox® Light | Zherox® Fixed System | Zherox® b-pack | Zherox® pass-box with HPE 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:
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.
A good hand washing and disinfection program results in better hygiene, counteracts cross-contamination, and reduces health risks to operators in classified environments.
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.
Use for cleanroom and laboratory cleaning in the pharmaceutical, biomedical, semiconductor, microelectronics, aerospace, health care, nutraceutical, and food industries.
Useful parameters in choosing cloth:
Getinge 's original DPTE® system is the ideal solution for sterile product transfer. The fully validated DPTE® system is available in disposable DPTE-BetaBag® and reusable Beta containers according to your needs. The main advantages for each solution are shown in the table below:
They are reusable aseptic transfer containers, available in polyethylene or stainless steel.
It is a single-use transfer solution that can be pre-sterilized and pre-filled with components through the Pharmaclean® repackaging service.
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.
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.
I nuovi guanti per isolatore in EPDM, CSM, Butile
Available in EPDM, CSM and Butyl, the gloves ensure quality and safety. Ideal for pharmaceutical and food production, they possess excellent gas and liquid impermeability, excellent chemical and sterilizing agent resistance.
The gloves are reliable even after 60 to 90 autoclave cycles, depending on the type of material.
Nitrile Gloves
Nitrile insulator/RABS gloves are resistant to vaporized hydrogen peroxide (VHP), isopropyl alcohol (IPA) and common disinfectants, and meet relevant standards for handling chemotherapeutic drugs. 100% tested against water leakage for reliable protection of people and products.
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.
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.
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.
The choice of the most suitable sampler depends on multiple factors:
AM offers single-use systems, which have the following advantages:
Ideal for reducing the risk of contamination in entry/exit routes from critical areas, locker rooms, transfer areas, corridors and air locks.
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.
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:
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.