AJ Manufacturing’s Stainless Steel Return Air Grilles – and All Our Custom Products – Provide Compliance Solutions
On November 1, 2022, US Pharmacopoeia published new standards for USP General Chapters 795 and 797. USP then provided a one-year timeframe in which facilities could begin making updates and reassessing priorities to remain compliant with these standards. November 1, 2023 – the deadline for enforcement of these standards – also requires facilities to enforce USP 800.
This means that relevant industries need to make plans now to ensure their HVAC systems are prepared to meet these regulatory requirements. Find out more below about industries where these standards apply, what they require, and how a custom manufacturer of air distribution systems and products can help you achieve compliance.
Who Needs to Act on USP 795, 797, and 800 Revised Compliance Chapters?
Custom HVAC manufacturers that deliver stainless steel return air grilles, as well as a wide variety of air distribution products and systems, keep a close eye on the USP’s evolving standards for the healthcare industry.
USP 795, 797, and 800 refer to standards that are set in place for settings – and for professionals – who create compounds of admixtures, reconstitutions, or dilutions for nonsterile, sterile, and hazardous drug preparation.
The settings that must abide by USP 795’s revised standards for nonsterile compound preparation include:
- Pharmacies
- Hospitals
- Healthcare institutions
- Patient treatment sites
- Physician’s practice sites
Read the complete FAQ for USP 795 for all the information your facility needs.
USP 797 refers to sterile compound preparation – and includes the following settings:
- Medical and surgical treatment sites
- Infusion facilities
USP 800 refers to handling hazardous drugs where there are safety risks involved for patients, workers, and the natural environment. Read the FAQ document on USP 800 for comprehensive information on this chapter.
What Should These Industries and Professionals Prioritize to Remain Compliant?
In terms of indoor air quality and ventilation, USP 795, 797, and 800 have different priorities due to the crucial differences between nonsterile, sterile, and hazardous drug preparation. These guidelines, quoted directly from USP’s FAQ pages on these revised chapters, provide direction in terms of air distribution guidelines.
UPS 795 contains the following language relevant to air distribution:
- This general chapter requires facilities to determine whether their work includes particle-creating activities that require a closed-system processing device; however, they are not required.
UPS 797 requires facilities that use sterile compounds to have:
- HEPA filters positioned over worktables in “integrated vertical laminar flow zones.”
- Air returns must be positioned strategically to cover this surface.
- Full-coverage HEPA filters above work surfaces in these zones.
- HEPA filters must not be placed in ventilation ducts – they should also be ceiling mounted.
- In cleanroom suites, air returns are required to be positioned low on the wall, unless a smoke study can prove that there is no evidence of stagnant air.
- Changing HEPA filters counts as “microbiological air and surface sampling” including HEPA filters in the ISO Class 5 PEC. Change prefilters does not require sampling.
USP 800 requires facilities that handle hazardous drugs (HDs) to have:
- HDs are required to be kept in “an externally ventilated, negative-pressure room with at least 12 ACPH [air changes per hour].”
- Containment Secondary Engineering Control (C-SEC) must be “physically separated, [and] have appropriate air exchange.”
- A C-PEC with ISO Class 5 or better must be used for HD sterile compounding. A Class II or III biological safety cabinet (BSC) or compounding aseptic containment isolator can be used. Acceptable Class II BSC types are limited to A2, B1, or B2.
A custom HVAC company that is accustomed to generating air distribution solutions for compliance readiness will be able to provide state-of-the-art products that ensure you meet regulatory guidelines as outlined by USP – or any regulatory body. Look for a manufacturer that engineers fan filter units, ceiling systems, stainless steel return air grilles, and any cleanroom- or critical-environment-ready product.
Partner with a Compliance-Focused Manufacturing Team for Your Stainless Steel Return Air Grilles and More
In many of the industries we serve, providing superior custom HVAC products isn’t just about business growth and ensuring safe, effective products and services are available in your market. Custom HVAC teams also provide the leading air distribution products for your industry to ensure you meet all compliance and regulatory requirements.
After all, your HVAC manufacturer is your business partner, and without an intensive focus on your needs, no manufacturer could truly say they are committed to your success. Whether you need support for building-code, healthcare, or manufacturing compliance – or any other regulatory standard required in your industry – an extraordinary team for custom HVAC will always have you covered, whether you need stainless steel return air grilles or any other signature product.
Learn more about the products you can secure with the right team for air distribution system manufacturing.