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

Cleanroom

Integrated floor + wall solutionsAltro Whiterock heat welded seam

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 hygenically 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.
 

PharmaceuticalsUSP 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 July 1, 2018.

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.

Cleanroom in use
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 resistanceStain resistance charts

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 hypchlorite, phenolic disinfectants, and germocidal 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.