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Table Of Contents

Technology Report

March, 2007

Siemens Industry, Inc. Page 1 of 6

Life Science Facilities–Good Storage Practices

Monitoring of Controlled Environments

This technology report summarizes monitoring

requirements for environmental storage units within

controlled environments in laboratories, animal

research, and production areas inside life science

facilities. A controlled environment may include any

of the following:

 Incubator

 Refrigerator

 Freezer

 Ultra-Low Freezer

 Environmental Chamber

 Cryogenic Storage

While the number of 483’s issued for temperature

control and monitoring has not been tabulated.

Citations issued by MHRA (UK) in 2003 and

2004, show temperature control and monitoring to

account for 24% of citations issued.

Section 501(a)(2)(B) of the Federal Food, Drug,

and Cosmetic Act states that:

“A drug shall be deemed to be adulterated—the

methods used in, or the facilities or controls

used for, its manufacture, processing, packing,

or holding do not conform to or are not operated

or administered in conformity with current good

manufacturing practice...

The FDA Good Manufacturing Practices (GMP),

Title 21, Code of Federal Regulations (CFR),

Part 210 states that parts 211 through 226 of

this chapter as they may pertain to a drug and in

parts 600 through 680 of this chapter as they

may pertain to a biological product for human

use, shall be considered to supplement, not

supersede, each other…”

1. Bishara, Rafik H., Cold Chain Management–An Essential

Component of the Global Pharmaceutical Supply Chain,

American Pharmaceutical Review, April 2006, pp 105-109

The stability of a drug can be influenced by the

environmental conditions of storage (temperature,

light, air, and humidity), as well as the package

components.

Current Industry Guidelines and

Regulations

 Part 58 GLP for Non-clinical Laboratory Studies

 Part 210 CGMP In Manufacturing, Processing,

Packing, or Holding of Drugs

 Part 211 CGMP For Finished Pharmaceuticals

 Part 600 Biological Products

 Part 606 CGMP Blood and Blood Components

 Part 640 Additional Standards for Human Blood

and Blood Products

 Part 820 Quality System Regulations

 Part 1271 CGTP for Human Cells, Tissues, and

Cellular Tissue Based Products

Critical Compliance Dates

 May 25, 2005–U.S. Food and Drug

Administration (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.

 August, 2005–United States Pharmacopeia

(USP) issued General Chapter <1079>, Good

Storage & Shipping Practices. This chapter

provides guidance concerning storage,

distribution and shipping of pharmaceutical

products. It describes proper procedures to

2. United States Pharmacopeia (USP) 2005, General Chapter

<1150> Pharmaceutical Stability, p 480

Document No. 1

49-925

Summary of content (6 pages)

PAGE 1
Technology Report March, 2007 Life Science Facilities–Good Storage Practices Monitoring of Controlled Environments This technology report summarizes monitoring requirements for environmental storage units within controlled environments in laboratories, animal research, and production areas inside life science facilities.
PAGE 2
maintain storage environments to ensure product integrity and stability, including appearance, until it reaches the end user. Who enforces the Guidelines? The FDA and the Center for Biologics Evaluation and Research (CBER) regulate biological products.
PAGE 3
Guidelines 3 developed by the National Cancer Institute (NCI) recommend the following be incorporated into protocols used for the collection of bio-specimens: Good Storage Practices  Base protocols on SOPs that are established using best practices.  SOPs should be printed and available to all laboratory personnel and dated according to most recent revision. FDA regulations do not provide direction on temperature conditions for storage. U.S.
PAGE 4
applied to the device. Alarms should be checked for correction function against specified design documents. Compromised Temperature Conditions Written Procedures and Records Excursions above or below established limits require a history leading up to and including the period out of tolerance and a documented rational for the excursion, including corrective actions.
PAGE 5
 Temperature sensors should be calibrated on a regular basis per manufacturer recommendations.  High/low alarms limits and alerts should be defined for all equipment being monitored.  Remote notification of alarms to alphanumeric pagers, numeric pagers, e-mail, and phones via voice or SMS (Short Message Service) is recommended to facilitate indication of critical storage temperature alarms to healthcare workers and facility maintenance staff.
PAGE 6
Product or company names mentioned herein may be the trademarks of their respective owners. © 2009 Siemens Industry, Inc. Siemens Industry, Inc. Building Technologies Division 1000 Deerfield Parkway Buffalo Grove, IL 60089-4513 USA Printed in the USA Document No.