Cleanrooms

Achieve USP 797 + USP 800 compliance with floor and wall solutions from Altro

USP 800 will become official in December of 2019. Introducing multiple new requirements for pharmacies, the new legislation is intended to protect pharmacists, nurses, pharmacy technicians, and others from the potential carcinogenic and teratogenic effects of hazard drugs (HDs).

Your business is to develop and deliver safe and effective pharmaceuticals to the marketplace. Our business is to provide you with durable, hygienic interior finishes that will support your work. Protect your personnel with a safer environment to handle chemotherapy medications and other hazardous drugs by achieving USP 797 + USP 800 compliance with Altro’s hygienic floor and wall system.

If you act last-minute to comply with the new legislation, you risk a slew of disruptive effects, including increased costs, inopportune facility downtime, federal litigation, and more. Minimize your risk by taking early, proactive steps to be compliant with USP 800.

Download our floor and wall finishes for laboratories and cleanrooms brochure

Recommended products

Altro Whiterock - ISO Class 2 and above cleanroom requirements

Interior finishes, such as wall paneling, are under close scrutiny in sterile application areas. Regulation requires that finishes must be smooth, non-porous, non-shedding, easy to clean and resistant to chemicals and staining. They must be installed seamlessly to prevent cracks, gaps and fissures.

Altro Whiterock’s smooth, durable, hygienic, and easy-to-clean surface can help you meet demanding regulatory requirements, maximize your production time, and ultimately increase your speed to market — with no surprises along the way.

As it meets ISO Class 2 and above cleanroom requirements, Altro Whiterock can be installed in even the most stringently controlled environments.

Once installed, Altro Whiterock wall panels are heat welded together using a color matched vinyl weldrod. This process creates a smooth, seamless surface that ensures there is no place to harbor contaminants.

2.5mm thick
4’ x 8’ and 4’ x 10’ panels
20-year warranty
White or color panels available
Stain resistant
Low VOC emitting
Meets ISO Class 2 cleanroom requirements

Discover Altro Whiterock

Altro Operetta - ISO Class 4 cleanroom

Altro Operetta is a robust floor perfect for medium to high traffic areas. It is easy to clean and maintain.

The product boasts a surface profile that is smooth, impervious, free from cracks and crevices, and nonshedding. Built with Altro Easyclean surface technology, Altro Operetta is resistant to disinfectant and other cleaning agents.

Combine with Altro Whiterock wall panels for areas requiring a seamless, floor-to-ceiling, hygienic surface.

2mm thick
2m wide
Withstands 2000psi
10-year warranty
25 colors
Stain-resistant
Low-VOC emitting
Meets ISO Class 4 cleanroom requirements
Non-toxic, non-polluting, no heavy metals

Discover Altro Operetta

Altro Symphonia - ISO Class 4 cleanroom

Bold, bright and beautiful - Altro Symphonia was engineered to deliver striking looks and bridge the gap between smooth and slip resistant flooring.

Altro Symphonia is smooth to the touch and easy to clean yet will secretly enhance pedestrian safety.

The product is impervious, free from cracks and crevices, and non-shedding. Built with Altro Easyclean surface technology, Altro Symphonia is resistant to disinfectants and other cleaning agents.

Combine with Altro Whiterock wall panels for areas requiring a seamless, floor-to-ceiling, hygienic surface.

2mm thick
2m wide
Withstands 2000psi
10-year warranty
41 colors
Enhanced slip resistance values
Stain-resistant
Low-VOC emitting
Meets ISO Class 4 cleanroom requirements
Non-toxic, non-polluting, no heavy metals

Discover Altro Symphonia

Case studies for cleanrooms

Integrated floor + wall solutions

Altro offers a complete floor and wall solution. It’s an integrated solution, which means it fits together perfectly to provide a hygienic, watertight surface. This doesn’t just offer the best possible protection against bacteria and contamination; it makes cleaning easy too.

Our integrated floor and wall solution is designed to provide a completely sealed environment from floor to ceiling and has been engineered to work together: the joined surfaces stay that way – joined. This gives you peace of mind that the surfaces will stay hygienically sealed.

Consistent quality

Altro products are always made from finest materials, which are consistent in grade and color across every sheet, batch, and joint to provide uniform high performance and ensuring compatibility between product lines.

Easy to keep clean

Used together, our products provide a robust, hard-wearing surface that resists stains, odors and chemicals. PVC is non-porous, nonshedding, and has a very high impact resistance, preventing damage that can trap bacteria compared to traditional surfaces.

Effective detailing

We know the devil’s in the details. That’s why our products have been constructed to maintain their integrity, meet the strictest hygiene standards, and to provide a perfect fit with no gaps or rough edges around joints and details — maintaining excellent hygiene becomes a whole lot easier with Altro.

Fully sealed

Altro Whiterock is a fully-bonded system with hygienic sealed edges, abutments and joints. It can even be sealed around pipes, ventilation outlets, light switches, plug sockets, and other fixtures and fittings.

Our floors are also fully sealed. When joined together with Altro Whiterock, they form a watertight covering - from floor to ceiling.

Thermoforming

Because our wall panels are thermoformed around internal and external corners on-site, they form an uninterrupted surface that’s resistant to impact and damage. There’s no need for unsightly corner trims which can form potential dirt traps that are difficult to access and clean.

Joint forces

Joints and junctions are a key part of system integrity. While we have multiple joining methods, in sterile areas Altro recommends heat welding for all joints - both wall panel to wall panel and wall to floor.

USP 797 regulations

Standards for compounding sterile preparations help
promote patient safety and prevent harm

USP (United States Pharmacopeia) 797 is a comprehensive regulation applying to institutions within healthcare and pharmaceutical industries where sterile compounds are prepared, stored and dispensed. The purpose of the regulation is to prevent infections in patients using pharmaceutical products, as well as to protect pharmacy staff members that are ordinarily exposed to pharmaceutical products.

The legislation affects facilities in which sterile products are prepared or compounded according to the manufacturer’s labeling and instructions.

Typical facilities affected by USP 797

Laboratories
Pharmaceuticals
Compounding facilities
Hospitals
Pharmacies

Requirements of floors and walls

Surfaces of ceilings, walls, floors, shall be smooth, impervious, free from cracks and crevices and nonshedding – required to meet ISO class clean rooms
Surfaces must be resistant to damage by disinfectant agents
Junctures of ceilings to walls shall be coved or caulked to avoid cracks or crevices where dirt can accumulate
Preferably, floors are overlaid with wide sheet vinyl flooring with heat-welded seams and coving to the sidewall

Areas must meet a range of ISO Cleanroom compliance for the area they will be installed

ISO Class 5 for Critical Areas
Segregated compounding areas
Aseptic processing rooms
Primary engineering control rooms
ISO Class 7 for buffer zones and low risk compounding areas
ISO Class 8 for ante-areas

USP 800: a race against time

Information, updates and resources for the safe handling of hazardous drugs

In March of 2014 the United States Pharmacopeial Convention
proposed new general chapter referred to as USP 800. This new
chapter applies to all personnel that compound hazardous drug
(HD) preparations, as well as all places where hazardous drugs are
prepared, stored, transported and administered in order to protect
healthcare workers, patients and the environment.

In the nearly two years since its initial publication in draft form,
USP 800 has undergone periods of public comment and revision.
The chapter is approved and is set to become official December 2019.

Due to provisions, USP 800 is being legally enforceable and may
subject pharmacies to both state board and FDA inspections.

This means facilities must comply with the requirements of USP
800 or they risk being shut down until these standards are met.

Path to compliance

Whether you’re looking to build a clean room or a negative-pressure compounding area, Altro can help. Altro manufactures products that can help facilities achieve USP 800 compliance.

We offer a floor and wall solution that is seamless, non-shedding, and heat-weldable. Our solution offers the right amount of hygiene and performance and is well suited for USP regulated facilities.

Stain resistance

Floors and walls in clean facilities are constantly exposed to a barrage of aggressive chemicals. Surfaces see everything from decontaminants to germicidal cleaners and disinfectants. It is important your facility is furnished with materials that will stand up to these powerful agents.

We have tested our floor and wall products against many of the commonly used chemicals: such as Sodium hypochlorite, phenolic disinfectants, and germicidal cleaners like Preempt and Simple Green D.

Even with this, it is still very important that maintenance teams are well educated on how to properly care for the floor and walls in a facility.

Steps to reduce staining

Select interior finishes that incorporate enhanced stain defense technology, like Altro
Specify colors appropriate for the application area
Use manufactured recommended cleaners
Train maintenance staff on proper care and cleaning procedures.
Make critical staining areas in a darker color, that can be pulled up and replaced if necessary

In areas subject to significant exposure, an additional stain resistant *coating can applied on site, to greatly increase the floor’s resistance to chemicals.

*Example coating is MARKNOMOR by Dr. Shutz

Altro can provide sample material free upon request.

Cleanroom and laboratory case studies

Altro has a proven track record of helping facilities achieve USP 797 and USP 800 compliance. Below are a few examples of some recent success stories.

Dover Hospital

After purchasing the Saint Clare's Health Network of New Jersey, Prime Healthcare Network worked with Posen Architects to improve hospital appearances and upgraded pharmacies to meet USP 797 and 800 regulations. Altro Wood, smooth sheet vinyl flooring in the color Autumn Maple was selected for use in the CT scan, Fluoroscopy and X-ray suites.

Discover the Dover Hospital case study

Medical Device Cleanroom

A Western Canadian medical device company was in need of a remodel and had to be ISO Cleanroom compliant. Because of the nature of these products, hygienic performance was a strict requirement of any interior finish used. Altro Whiterock hygienic wall panels were chosen for the cleanroom.

Discover the Medical Device Cleanroom case study

TriStar Summit Medical Center

Summit chose Altro Whiterock and Altro Maxis Unity to create the clean environment critical for areas in which pharmaceuticals are created and/or mixed. Their USP 797 inspection was passed with flying colors and the inspectors were very satisfied with Altro products.

Discover the TriStar Medical Device case study

Details

We know that when it comes to achieving USP compliance the devil is in the details. Therefore we have created all the transition details you need for a successful installation.

Whether you’re talking about floor to wall transitions or wall to ceiling transitions we’ve got you covered. The Altro floor and wall system can integrate smoothly using heat welds and sanitary sealant. Please see below for a snapshot of the important details.

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