AM Production
Our line
of production
AM's production boasts 4 patents and 25 registered trademarks, the result of 35 years of activity and constant commitment to research and development of solutions suitable for the Life Sciences market.
The production environments, 1000sqm of Grade C Operational cleanroom and an innovative technology hub, ensure production meets the regulatory requirements of the Life Sciences industry.
The Quality Management System verifies every step of the processes, creating synergy between operating methods, goals and results shared with our customers.
Pharmaclean®
Pharmaclean®is AM's brand dedicated to the study, production and marketing of high-quality cleanroom consumables, representing the benchmark for those working in controlled environments.
Pharmaclean®stands out for its ability to offer tailored solutions that optimize efficiency, reduce risk, and ensure maximum compliance of operations in protected environments, where even the invisible detail makes a difference.
Manufacturing sites in Italy specialize in Tyvek® items designed for packaging, sterilization and material transfer processes in contamination-controlled environments.
Production, featuring the proprietary Safe4Clean® system for decontamination of raw materials at the entrance of the production cycle, takes place in Grade C Operational environments and complies with the quality standards required by GMP Annex 1.
Zherox® is AM's brand specializing in environmental biodecontamination systems, synonymous with innovation, effectiveness and safety for operators.
Thanks to its unique Electromagnetized Hydrogen Peroxide (HPE) technology, which uses a solution with less than 8 percent H₂O₂, Zherox® ensures uniform and effective biodecontamination on all surfaces, including hard-to-reach areas, setting new standards in the industry.
The versatility of the system allows its application in different solutions-mobile, stationary, portable and pass-box systems-to meet specific operational needs.
The advantages
- validated effectiveness
- Reduced cycle times
- maximum compatibility with all materials
- Maximum automation
- Data Integrity
HPE Technology
Optimized diffusion of the solution capable of reaching 100% of the treated area.
Pharmaclean® Solution
Sterile broad-spectrum biocide effective on bacteria, fungi, spores and viruses, especially suitable for aerial spraying.
Zherox®
LAF - Laminar Flow
AM designs, manufactures and validates standard and custom laminar flows according to ISO 14644-1.
The flexibility of AM laminar flows allows the design to be adapted to the actual needs of the customer.
- Standard modules, which can be assembled according to varying sizes and geometries
- customized solutions
- down-cross hoods
- Fluxed trolleys, with no external power supply required, designed for transfers between Class A areas through lower classification areas safely
- Traditional and next-generation material passes with HPE biodecontaminant technology
- RABS
- air showers and dust collectors
- fluxed cabinets
Our plants are easily integrated with BMS systems, ensuring maximum automation.
A team of qualified designers, technicians and operators assists customers during all phases, from development to delivery and after-sales service.
Advanced technologies and design, adaptability to spaces and operational excellence.
Sectors: pharmaceutical, chemical, electronics and food; manufacturing and research.
AM designs and manufactures particle and microbiological monitoring systems with integrated automation, complying with cGMP, GAMP and ISO guidelines.
One dedicated team, one contact person for all stages of the implementation process of a particle monitoring facility.
- initial inspections
- system planning and design
- Implementation of integrated software developed in harmony with the needs of the requesting company
- installation and testing
- validations to operator trainings
Benefits
Installations tailored to the needs of our customers.
Components
A complete range of accessories and components for effective and safe implantation.
Environmental monitoring
Smoke generator for visual control visual control of air flows.
MyFog® is a unique and innovative tool!
- Works with process water
- One operator
- Remote control
- Quality dense smoke
THE BENEFITS OF MYFOG®
A single operator, with the standard remote control option, can manage the unit's start/stop, intensity and speed of smoke regulation.
MyFog® has an intuitive interface with a touch screen that allows the operator to have immediate diagnostics and display of key operating parameters.
Smoke study
MyFog® is the ideal tool for performing Smoke Study in critical environments.
MyFog®
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Tyvek® covers and bags
Pharmaclean® products for sterilization, transfer and storage of materials ensuring particle and microbial protection, are completely made of DuPont™ Tyvek® material and offer total safety and durability, are customizable and easy to use. All products come with a certificate of compliance and irradiation certificate where required.
Full supply chain traceability is also guaranteed.
Production takes place in Grade C Operational cleanroom .
features and benefits
- ability to customize shapes and sizes
- Tear and puncture resistant
- easy to apply and remove
- Substantial reduction in operational time
- low particle release
- excellent microbiological barrier
- uniform steam penetration
- autoclavable
- also available in sterile packaging
Pharmaclean® COVERS ARE CUSTOMIZABLE IN SHAPES AND DIMENSIONS.
Our product specialists support the customer from data collection aimed at feasibility study, to sample production with related testing, to batch release with attached documentation.
Bags and reels made of TYVEK®-PET/PP
bags and rolls made of Tyvek® 1073B and PET/PP material for autoclave sterilization of components and tools, manufactured and packaged in our Grade C operational cleanroom . Tyvek® and PET/PP undergo decontamination with the exclusive Safe4Clean® system, which ensures a significant reduction in viable and total particles. The strength and breathability qualities of Tyvek® 1073B combined with the transparency of PET/PP allow the sterilized contents to be preserved while maintaining total visibility.
The Pharmaclean® line offers a wide range of products and solutions:
- Heat seal bags
- Heat seal gusseted bags
- Self seal bags
- Heat seal reels
New Product
The ideal solution for sterilization processes
The new Tyvek®-PET/PP pouch with process indicator and lot number ensures complete alignment with Annex 1 requirements. The validated printing process ensures there is no residue on the product and in the autoclave, while the printing of the batch number and product code makes the entire process fully traceable.
GMP QUALITY
- Grade C operational cleanroom production
- Safe4Clean® decontamination process for reducing viable and total particles from raw material surfaces
- excellent peelability, very low particle release
- checks on raw materials and finished products for use in cleanrooms
- possibility of production site audit
EFFECTIVENESS
- Maximum effective antimicrobial barrier
- excellent resistance to sterilization cycle, tears and punctures
- Facilitated opening (thumb notch) and Chevron welding
FLEXIBILITY
- possibility of applying hole for attaching bags inside insulators
- pre- and after-sales support from our dedicated staff
Repackaging service
In cases where materials needed for pharmaceutical production are not adequately packaged, the pharmaceutical customer needs to arrange for decontamination and cleanroom repackaging to make them suitable for use in sterile and contamination-controlled environments.
The Pharmaclean® team, operating in accordance with its Quality Management System, is able to provide the complete consulting and management of the repackaging service.
The Pharmaclean® Quality Unit, in collaboration with the customer's team, analyzes the need, develops an SOP in accordance with GMP, and enters into a Quality Agreement in order to standardize the process and ensure quality requirements. All with a focus on service cost and delivery time.
Pharmaclean® also offers a custom contract repackaging service for pharmaceutical applications in DPTE-Betabag® Getinge.
The repackaging service is carried out in a classified environment by qualified personnel in accordance with procedures and operating instructions agreed with the customer and GMP guidelines.
LYOPHILIZATION
Tray Cover
Made of LDPE to hold the product throughout the bulk freeze-drying process: double-sealed corners allow the cover to adhere perfectly to the tray.
MICROELECTRONICS
Wafer separator
Tear-resistant Tyvek® sheets with antistatic coating for separating and protecting wafers in the semiconductor industry. Low particle release to avoid particles and scratches.
Tyvek® sheets are decontaminated with the Safe4Clean® system to ensure reduction of viable and total particles on raw material surfaces.
HPE Technology
A hydrogen peroxide solution of less than 8% 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 has a high concentration of hydroxyl radicals and reactive oxygen species (ROS) that can damage microorganisms through oxidation of proteins, carbohydrates and lipids.
The electromagnetic field imparts an electrostatic charge to the fog, which thus acts like a gas because of the mutual repulsive activity of the positive charges.
The result is a high diffusion of the solution that is able to reach 100% of the treated area.
The resulting products, oxygen and water, leave no residue on surfaces.
Applications
The different systems can be used in the following applications:
- pharmaceutical industry
- research and laboratories
- biotech
- hospitals and health care
- offices
- transportation
Multiple®
Multiplo® is an independent laminar flow unit with HEPA filter and fan, made in 4 standard models.
The modular structure allows assembly according to variable dimensions and geometries to meet the requirements of Class ISO5 (according to ISO 14644-1), peculiar to certain industries and specific stages of production.
Down-Cross Hoods
The AM down-cross hood is a vertical laminar flow unit for weighing rooms or sampling rooms; it ensures operator exposure levels of less than 100μg/m³ TWA, which can be improved with the use of flexible or rigid screens to less than 10μg/m³ TWA. The finishes are of high quality, ideal for the pharmaceutical sector.
MyBox® - Material pass-throughs
Using integrated low concentration hydrogen peroxide systems (less than 8%) with HPE technology, our decontamination chambers guarantee a bacterial load reduction level greater than log 6 in extremely rapid times with the possibility of use for all thermolabile materials and electronic components.
MyBox® is manufactured according to GMP standards for pharmaceutical environments with high-quality materials and finish, and is capable of running automatic biodecontamination cycles through integrated PLC, adapting to individual load specifications.
MyBox® can be easily installed for the passage of material from C/D classified areas into sterile Grade B areas, ensuring the sterilization of their external surfaces. This device is essential when the products/components to be sterilized are not autoclavable.
Air showers
System for decontaminating personnel entering a contamination-controlled area. The shower is arranged for the entry and exit of one person at a time and is equipped with two access doors, normally open and interlocked with each other to prevent simultaneous opening.
The air shower also allows the transfer of materials on pallets from an unclassified room to a classified area (e.g., Grade D).
Cart2Count - Fluxed Cart
ISO5-class material transfer systems with continuous particle monitoring.
The Cart2Count is designed to transfer materials from one Grade A zone to another Grade A zone, crossing a Grade B, without connection to the power supply (battery life up to one hour) in complete safety. The Cart2Count houses an on-board continuous particle counter.
Dimensions are fully customizable according to request.
Fluxed cabinets
Fluxed cabinets are made of AISI 304 stainless steel with ventilation and air filtration to ensure ISO5 conditions in the inner compartment with closed doors. Scotch Brite finish (polished on request) for both exterior surfaces and interior compartment.
Totally customizable dimensions.
RABS
The push to implement more modern and safer technologies in aseptic pharmaceutical manufacturing is urging production sites and processes to change rapidly to meet the increasingly stringent requirements of regulatory bodies.
The use of physical separations (Restricted Access Barrier Systems) between operator and product should be considered as a primary solution when designing new filling lines or renovating existing ones. AM proposes feasibility studies to align production lines with the most innovative design solutions.
Ability to custom design RABS with doors equipped with glove flanges positioned in accordance with the specific requirements of each process.
Use of transfer ports to eliminate contamination due to the passage of critical process materials through Grade B areas to Grade A areas.
Benefits
COMPLETELY TAILOR-MADE
- pre-sales feasibility analysis
- A design and development team fully at your disposal
- No limits on integration with existing machines and software
IMMEDIATE
- immediate reporting
- Complex reports obtainable with a single click
- Macro operations translated into simple software operations
Sure
- compliance with the principles of data integrity
- system-controlled accesses
- reporting in accordance with Federal Register regulations CFR 21 part 11 and EudraLex Vol 4 Annex 11 regarding electronic signature and electronic records management
- system-controlled accesses
PROJECT PLAN AND VALIDATION
The design and implementation of continuous monitoring systems are accompanied by validation documentation as required by regulations.
- drafting the functional specifications of the system
- design plan
- program specifications
- hardware specifications/system installation details
- structural notes
- system/FAT testing
- hardware and software design
IQ/OQ
- user manuals
- staff training certificates
- change control/report errors
- validation report
Components
- Remote or built-in pump particle counters
- SmartProbe® self-closing sampling devices (AM patent)
- Membrane or impact microbiological sampling heads
- electrical control panel
- SCADA supervision system
- Interfacing with process and production machines
SmartProbe®
AISI 316 stainless steel 1 CFM isokinetic sampling probe with automatic closure.
Lighthouse Apex35
Particle Light Scattering measurement sensor with centralized vacuum system.
Lighthouse P5
Light Scattering particle measurement sensor with built-in vacuum pump.
Smoke Study
AM has been offering smoke study service for years.
Expertise, combined with experience, has generated an operating mode that can be summarized in a fundamental concept: the smoke study cannot and should not be a simple airflow check, but a careful analysis of all the elements that contribute to contamination control. It is no coincidence that in recent years, inspection agencies have used smoke studies as a verification test that contemplates yes airflows, but also and especially operational dynamics.
The In Operation situation thus becomes preponderant over the At Rest situation.
MyWipe®
MyWipe® is the Pharmaclean® cloth dedicated to general cleanroom cleaning and specific applications such as critical environments and sterile areas.
Available in polyester and polyester/cellulose, in single and double layers, it has excellent absorbency properties.
The welded edge ensures extremely low levels of fiber and particle release.
Washed and cleanroom packed, it is available sterile and nonsterile.
Cleaning equipment and accessories
Pharmaclean® offers three different types of mops for floors, shelling, walls and ceilings.
The mops, which are ideal for ergonomics and material quality, are accompanied by accessories such as polyester and polyester/cellulose cloths and covers, developed for applications requiring low particle release and high absorption.
All covers are available in sterile versions.
Cleaning accessories
Squeegees, waste scoops, wringers, bag holders: all accessories are made of AISI 304 Stainless Steel with a polished finish.
Simple and well-equipped carts and buckets, easily maneuverable even in small areas.
Bucket Liners
A simple solution to avoid the risk of cross-contamination during the use of buckets, the maintenance of which involves sanitization problems and, in the case of autoclave sterilization, high costs and high space requirements inside the autoclave.
Bucket liners allow for reduced exposure of buckets to chemicals and simplify the disposal of sanitizing solution. They also allow buckets and carts to be kept within the sterile area for subsequent cleaning shifts.
Pharmaclean® tear-off mats
The antimicrobial additive in Pharmaclean® tear-off mats, contained in the adhesive portion, ensures a substantial reduction in cross-contamination. They have numbered corners to facilitate tearing and removal of individual layers. They are available in different packaging, colors and sizes, with the possibility of matching with polystyrene frame with non-slip bottom for perfect positioning of the mat on any floor.
cleanroom stationery
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.
Pharmaclean® Solution
Sterile broad-spectrum biocide effective on bacteria, fungi, spores and viruses, especially suitable for aerial spraying. The mixture is composed of 7.8% hydrogen peroxide and WFI water, filtered to 0.2 microns and filled aseptically in previously irradiated containers. Each 5L drum with cap, ready to use, is triple-bagged and carries lot number with expiration date. Certificate of analysis, including sterility, available with each lot.
- Decomposition in water and oxygen resulting in no residues
- Peroxide concentration less than 8% (4 times lower than solutions commonly used by VHP systems)
- maximum material compatibility
- canister traceability through RFID (ZHEROX®)