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Table Of Contents

Technology Report

March, 2007

Siemens Industry, Inc. Page 1 of 6

Healthcare Facilities–Good Storage Practices

Monitoring Controlled Environments

This technology report summarizes practices for the

monitoring of controlled environments found in

healthcare facilities such as, but not to be limited to:

 Pharmacies

 Laboratories

 Blood banks

 Morgues

 Food services

A controlled environment may be any of the

following:

 Incubator

 Refrigerator

 Freezer

 Ultra-low freezer

 Environmental chamber

 Cryogenic storage

U.S. Food and Drug Administration (FDA)

regulations state that improper holding environments

can cause a drug, biological agent, or tissue to

become adulterated. Improper storage conditions,

such as inaccurate temperature control in controlled

environments, have an impact on patient safety. MM

2.20.2 in the Joint Commission on Accreditation of

Healthcare Organizations (JCAHO) Comprehensive

Accreditation Manual for Hospitals (CAMH2006):

The Official Handbook states that: Medications are

stored under conditions suitable for product stability.

Current Industry Guidelines and

Regulations

 United States Pharmacopeia (USP) 2005:

 <797> Compound Sterile Preparations

 <1079> Good Storage & Shipping Practices

 U.S. Food and Drug Administration, 21 CFR:

 Part 110 Current Good Manufacturing

Practice (CGMP) for Manufacturing,

Packaging, or Holding Human Food

 Part 120 Hazard Analysis and Critical

Control Point (HACCP) for Food Safety

 Part 600 Biological Products

 Part 606 CGMP Blood and Blood

Components

 Part 610 General Biological Products

Standards

 Part 640 Additional Standards for Human

Blood and Blood Products

 Part 1271 CGTP Human Cells, Tissues, and

Cellular and Tissue-based Products

(HCT/Ps)

 Centers for Disease Control and Prevention

(CDC) Guidelines for Maintaining and Managing

the Vaccine Cold Chain

Critical Compliance Dates

 December 18, 1995–FDA adopted the Hazard

Analysis and Critical Control Point (HACCP) for

use in the seafood industry and additional food

industries such as: meat (1998) and juice

(2001). The FDA is now considering establishing

HACCP as the food safety standard throughout

the food industry. In 1999, FDA incorporated

HACCP into the Food Code for the prevention of

food-borne illness in restaurants, grocery stores,

and institutions such as nursing homes and

hospitals.

 October 24, 2003–CDC Guidelines for

Maintaining and Managing the Vaccine Cold

Chain.

Document No. 1

49-208

Summary of content (6 pages)

PAGE 1
Technology Report March, 2007 Healthcare Facilities–Good Storage Practices Monitoring Controlled Environments This technology report summarizes practices for the monitoring of controlled environments found in healthcare facilities such as, but not to be limited to:  Pharmacies  Laboratories  Blood banks  Morgues   Food services A controlled environment may be any of the following:  Incubator  Refrigerator  Freezer  Ultra-low freezer  Environmental chamber  Cryogenic storage
PAGE 2
  May 25, 2005–FDA issued 21 CFR Part 1271 CGTP for Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps), representing the last of three FDA rules that have been developed to improve the safety of HCT/Ps. July 1, 2005–With the CGTP rule, JCAHO revised its standards for Laboratory Accreditation Program (QC5.300, QC5.310 and QC5.
PAGE 3
were outside the required range without evidence of action. 1 years. 6 Storage temperatures for blood bank products are shown in Table 1. 7 When storing vaccines it is important to maintain records for at least three years. 2 Table 1. Storage Temperature for Blood Bank Products. Human Cells and Tissue Banks Blood Product Type Storage Temp (°C) CGTP for HCT/Ps requires that appropriate temperature and temperature limits for storage be established at each step of the manufacturing.
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 Establish corrective actions if monitoring shows that a limit was exceeded than 25°C (77°F); and that allows for excursions between 15°C and 30°C (59°F and 86°F). 12  Establish procedures to ensure the system is working properly Freezers–An increasing number of blood and biotechnology products must be stored frozen. These labeled products must be stored below -5°C (23°F) (freeze) and below -15°C (5°F) (deep freeze), or they may show a range of -15°C to -20°C (5°F to 4°F).
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details of any adjustments made or corrections applied to the device. Alarms should be checked for correction function against specified design documents. elevators). This kind of planning will help assure that emergency power feeds critical systems. 14  Temperature sensors shall be NIST-certified or guaranteed by manufacturer to meet NIST standards. Temperature sensors should have an accuracy of ±0.25°C (32.5°F).
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  Refrigerators and freezers used to store drugs should:  Be well maintained  Equipped with alarms  Free from frost buildup  Have sensors for continuous monitoring and alarms located at points representing extreme temperatures Written procedures should be available describing the action to be taken in the event of temperature excursions outside the labeled storage conditions. Product or company names mentioned herein may be the trademarks of their respective owners.