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Technology Report

September, 2018

Siemens Industry, Inc. Page 1 of 8

Document No. 149-224

Hospital Pharmacy–USP Compounding Standards

Environmental Requirements for USP 795 & 797 Compliance

This technology report summarizes the

environmental requirements for compounded sterile

preparations (CSPs) and for compounded nonsterile

preparations (CNSPs). Compounding occurs in the

following settings:

• Hospitals

• Outpatient treatment clinics

• Infusion facilities

• Pharmacies

• Physician offices

• Long-term care facilities

This report is based on the current industry

guidelines listed in the following section, as well as

the experience of knowledgeable healthcare facility

designers.

Regulatory requirements constantly evolve.

This technology report is based on United States

Pharmacopeia (USP) <797> proposed revision

dated July 2018 and USP <795> proposed

revision dated March 2018.

Section 503A of the Federal Food, Drug, and

Cosmetic Act states that compounded

preparations prepared by a licensed pharmacist

or physician qualify for an exemption from the

requirements of current Good Manufacturing

Practice (cGMP) if they are compounded in

compliance with the USP chapters on pharmacy

compounding

Current USP Guidelines

• The current version of USP <795> became

official on January 1, 2014.

• An update to USP <795> was proposed for

public comment on March 30, 2018.

• The proposed update to USP <795> is expected

to be official on December 1, 2019.

1. The FD&C ACT section 503A contains additional exemption

requirements.

• The current version of USP <797> became

official on June 1, 2008.

• An update to USP <797> was proposed for

public comment on July 27, 2018.

• The proposed update to USP <797> is expected

to be official on December 1, 2019.

Center for Medicare and Medicaid

Services (CMS) Compliance Date

• October 30, 2015–Condition of Participation

was updated to require hospitals to comply with

USP <797> and other relevant USP-NF

(National Formulary) chapters.

USP <795> Facility Requirements

USP <795> describes the minimum practices and

quality standards for the preparation of CNSPs.

CNSPs must be prepared in a space that is

specifically designated for compounding. The

compounding area must be separated from the rest

of the facility. Nonsterile preparations must be

compounded in a separate and distinct space from

sterile compounding.

Any activity that may result in airborne contamination

(powder substance) must be performed in a

containment ventilated enclosure (CVE).

CVE

A full or partial enclosure that uses ventilation

principles to capture, contain, and remove

airborne contaminates through high-efficiency

particulate air (HEPA) filtration

USP <797> Facility Requirements

USP <797> describes the minimum practices and

quality standards for the preparation of CSPs.

Summary of content (8 pages)

PAGE 1
Technology Report September, 2018 Hospital Pharmacy–USP Compounding Standards Environmental Requirements for USP 795 & 797 Compliance This technology report summarizes the environmental requirements for compounded sterile preparations (CSPs) and for compounded nonsterile preparations (CNSPs). Compounding occurs in the following settings: • The current version of USP <797> became official on June 1, 2008. • An update to USP <797> was proposed for public comment on July 27, 2018.
PAGE 2
USP <797> divides CSPs into two classifications: Category 1 and Category 2 preparations. The definition and requirements are as follows: Category 1: • • • Category 1 CSPs are those with an assigned beyond-use date (BUD) of 12 hours or less at controlled room temperature or 24 hours or less if refrigerated. Category 1 CSPs must be prepared in a primary engineering control (PEC) which provides an ISO Class 5 environment.
PAGE 3
Failure of Cabinet – The impact that a cabinet failure will have on the room environment must be considered during the design process. For example, consider a system with the following cabinets: Negative pressure barrier isolators, Class II BSC Type B1, and Class II BSC Type B2. If the building exhaust or cabinet exhaust fails, the cabinet will become pressurized, causing airflow from the work area to flow back into the room. Therefore, these cabinets should have their exhaust ducted to the outside.
PAGE 4
The PEC must be located so that it is not affected by air currents or streams from heating, ventilation, and air conditioning (HVAC), personnel, or doors. ISO 7 and ISO 8 rooms must be physically separated, with walls and doors between them and with controls to prevent the flow of lower-quality air into the controlled area. ISO 7 areas must have at least 30 air changes per hour (ACPH), and at least 15 ACPH must be HEPAfiltered fresh air. ISO 8 areas must have a minimum of 20 ACPH.
PAGE 5
Air Changes The required rate of air changes is dictated by the internal generation of particles from operators and building elements such as walls, ceiling, floor, and so on. The ISO 7 buffer room must maintain an ACPH value of not less than 30. The ACPH of 30 can include re-circulated HEPA-filtered air, but at least half of the ACPH must be HEPA-filtered fresh air. The ISO 8 ante-room must maintain an ACPH value of not less than 20.
PAGE 6
• Ceilings with inlaid panels should be impregnated with a polymer to render them impervious and hydrophobic. Caulk around each perimeter to seal the panels to the frame. • Walls may be constructed of panels locked together and sealed or can be made of epoxycoated gypsum board. • Floors should be overlaid with wide sheet vinyl flooring with heat-welded seams and coving at the sidewall. • Avoid dust-collecting overhangs and ledges, such as ceiling utility pipes and windowsills.
PAGE 7
• Temperature and Humidity monitoring equipment must be calibrated or verified for accuracy at least every 12 months or as recommended by the manufacturer. Storage conditions (as defined in USP <659>) are as follows unless more restrictive conditions are provided from the manufacturer: • Differential pressure monitoring equipment must be calibrated or verified for accuracy at least every 6 months.
PAGE 8
Product or company names mentioned herein may be the trademarks of their respective owners. © 2018 Siemens Industry, Inc. Siemens Industry, Inc. Building Technologies Division 1000 Deerfield Parkway Buffalo Grove, IL 60089-4513 USA Printed in the USA Document No.