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Technology Report

September, 2018

Siemens Industry, Inc. Page 1 of 8

Document No. A6V11520001

Hospital Pharmacy–USP Compounding Standards for Hazardous Drugs

Environmental Requirements for USP <800 >Compliance

This technology report summarizes the

environmental requirements for handling hazardous

drugs (HDs). The use and handling of HDs occurs in

the following settings:

• Hospitals and other healthcare institutions

• Patient treatment clinics

• Pharmacies

• Physician offices

• Veterinarian offices

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) <800> proposed revision

dated September 2017, USP <797> proposed

revision dated September 2015, 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

• USP <800> was proposed as a new chapter in

March 2014. The final version was released in

February 2016. The expected official date of

USP <800> is December 1, 2019.

• 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.

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

requirements.

• The proposed update to USP <795> is expected

to be official on December 1, 2019.

• The current version of USP <797> became

official on June 1, 2008 and includes

requirements for both compounded sterile

preparations (CSPs) and HDs.

• An update to USP <797> was proposed for

public comment on September 25, 2015.

• 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 Chapter Overviews

USP <800> describes the practice and quality

standards for handling HDs. The National Institute

for Occupational Safety and Health (NIOSH)

maintains a list of antineoplastic and other HDs used

in healthcare.

USP <800> defers to the appropriate USP chapter

(795 or 797) for compounding practices.

USP <795> describes the minimum practices and

quality standards for the preparation of compounded

nonsterile preparations (CNSPs).

USP <797> describes the minimum practices and

quality standards for the preparation of CSPs.

USP <797> divides CSPs into two classifications;

Category 1 and Category 2 preparations. The

definition and requirements are as follows:

• Category 1 CSPs are those with an assigned

beyond-use date (BUD) of 12 hours or less at

Summary of content (8 pages)

PAGE 1
Technology Report September, 2018 Hospital Pharmacy–USP Compounding Standards for Hazardous Drugs Environmental Requirements for USP <800 >Compliance This technology report summarizes the environmental requirements for handling hazardous drugs (HDs).
PAGE 2
controlled room temperature or 24 hours or less if refrigerated. • Category 2 CSPs are those with an assigned BUD of greater than 12 hours at controlled room temperature or greater than 24 hours if refrigerated. Receipt of HDs HDs must be unpacked in an area that has neutral or negative pressure relative to the surrounding area. HDs must not be unpacked in the sterile compounding area or in any positive-pressure area.
PAGE 3
Equipment (Primary Controls) Although the ventilation system designer does not normally select the type of ventilated cabinets that are used within the compounding area, the designer must know the type of protection (personnel, product, and/or environment) provided by the units. This knowledge ensures that the ventilation system design will address the exhaust and makeup air requirements of these cabinets.
PAGE 4
If facilities are designed with ante-areas and buffer areas, those areas must be separate from the general pharmacy and must control for these environmental conditions: • Particle count • Temperature • Humidity • Differential pressure (D/P) • Air changes Buffer and Ante-Area Requirements The environment is designed to have the C-PEC located in the buffer area (negative pressure).
PAGE 5
Room Exhaust Temperature and Humidity Return openings from the room should be low on the walls 3, to promote a downward flow of air from the supply to return, sweeping contaminants to the floor and away from the product. Perforated floors are not recommended due to the difficulty in cleaning them. Maintain the temperature below 68°F (20°C) and the humidity below 60% in the CSP compounding area.
PAGE 6
Cleanroom Design Considerations The following list describes important design criteria for cleanrooms 5: • Construct walls, floors, ceilings, fixtures, shelving, counters, and cabinets so that the surfaces are accessible for cleaning and so that spaces in which microorganisms and other contaminants can accumulate are minimized. • Select materials that will not deteriorate with use and affect particle control and contribute to contamination.
PAGE 7
HVAC Design Considerations • Before developing the project design, assess the pharmacy HVAC system for the following:  Does the air handler serving the pharmacy have enough cooling capacity to meet the cooling requirements for the cleanroom?  Does the air handler serving the pharmacy have enough static pressure to meet the static pressure requirements of the HEPA-filtered diffusers?  Can the HVAC terminal equipment be located in an area adjacent to the pharmacy to facilitate good maintenance pract
PAGE 8
Controlled storage areas in the pharmacy should be monitored at least once per day and the results documented on a temperature log. If the facility uses a continuous temperature-monitoring device or system, then personnel must verify at least once daily that the recording device is functioning properly.