AM Production

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.

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.

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.

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.

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.

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.

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.

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).

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 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.

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® 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.

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.

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.

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.

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.

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.