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Cleanrooms + compounding

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

Made effective in 2019, USP 800 introduces multiple new requirements for pharmacies. 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).

Altro Whiterock installed in a cleanroom

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. 

USP 797 regulations

Altro installed in a clean facility

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
  • Pharmaceutical manufacturing plants
  • Compounding facilities
  • Hospitals
  • Pharmacies

Requirements of floors and walls

  • Surfaces of ceilings, walls and floors shall be smooth, impervious, free from cracks and crevices and nonshedding – required to meet ISO Class cleanrooms
  • Surfaces must be resistant to damage by disinfectant agents
  • 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: ensuring compliance

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.

Desk in a lab

In the nearly two years since its initial publication in draft form, USP 800 has undergone periods of public comment and revision. Following these revisions, the chapter was approved and became effective for compounding and pharmaceutical facilities in 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 cleanroom 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

Altro installed in a cleanroom hallway

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. You’ll see the results here. For a full report, please visit our website.

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 manufacturer 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 be applied on site, to greatly increase the floor’s resistance to chemicals.