Bot Detector
IJPC Seal
Download FREE Sample Issue or Article
LEARN MORE
Subscribe Today
A subscription to IJPC provides on-line access to full-text, full-color, printable PDF copies of your subscribed issues, individual articles, and purchased archives.

PostScription: Cleanroom Standards

Author(s):  Fitzpatrick Mike, Goldstein Ken

Issue:  Mar/Apr 2004 - Overview of USP Chapter <797>
View All Articles in Issue

Page(s):  160

PostScription:  Cleanroom Standards Page 1

Download in electronic PDF format for $75

Abstract:  This brief article is a reprint of an article that originally appeared in CleanRooms magazine, a Penn Well publication. The authors look at the subject of standards, considering some of their strengths and weaknesses. On the plus side, they mention that standards provide fundamental information, a basis for moving in new directions, a means of formally reviewing projects to identify strengths and weaknesses, a common starting point and means of communicating, a way to save time and a means of simplifying and encouraging free trade. Disadvantages include the potential of becoming quickly outdated, the possibility of terminology’s remaining undefined if critical terms are too narrowly defined, the capability of being misused and the potential of delaying or stopping technological development. The authors conclude that it is necessary to choose and read standards carefully, use them appropriately and participate in groups to modify standards that need improvement.

Related Keywords: Cleanroom, standards for, Fitzpatrick, Mike, Goldstein, Ken, PhD, PostScription, cleanroom, standards for

Related Categories: BUSINESS, INFUSION, LEGAL, PARENTERALS, STERILE PREPARATIONS, SUPPORT, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS

Printer-Friendly Version



Related Articles from IJPC
Title/Author
(Click for Abstract / Details / Purchase)
Issue/​Page
View/Buy
PostScription: Cleanroom Standards
Fitzpatrick Mike
, Goldstein Ken
Mar/Apr 2004
Pg. 160

Pharmacy Cleanroom Project Management Considerations: An Experience-Based Perspective
Kastango Eric S
, DeMarco Sam
May/Jun 2001
Pg. 221-225

View Sample
Expecting the Expected: Planning Considerations for Cleanroom Construction
Roberts Patricia A
, Kroon Laura
Jul/Aug 2021
Pg. 276-281

Sterile Basics: How to Know if Your Cleanroom Can Consistently Operate Within a State of Control
Summers Amy
, Stephens Pat
Jan/Feb 2023
Pg. 39-46

Cleanroom Cleanliness
Mulder Kyle
Jan/Feb 2021
Pg. 6-12

Maintenance of the Cleanroom
Allen Loyd V Jr
Jul/Aug 2001
Pg. 313

Safer Sterile Compounding: Choosing and Using Disinfectants for the Cleanroom
Kastango Eric S
, Douglass Kate, Patel Kedar, Givehchi Babak, Brister Paul, Postlewaite Jay, Taraban Laura
Jul/Aug 2015
Pg. 268-278

Sterile Basics of Compounding: Contamination Control Strategies, Part 2
Summers Amy
Nov/Dec 2022
Pg. 497-504

Depyrogenation Options for the Compounding Cleanroom
Weller Tom
, Bell Jeff, Dullinger Roger, Allen Vern, Anthenat Bruce
Nov/Dec 2014
Pg. 446-454

PreScription: Standards, Legal Standards, and Accreditation
May/Jun 2006
Pg. 162

Standard Operating Procedure: Incubator Temperature Monitoring
Allen Loyd V Jr
May/Jun 2003
Pg. 228-229

Advanced Compounding; How to Investigate Microbiological Excursions at a Sterile Compounding Facility
Summers Amy
Mar/Apr 2023
Pg. 114-121

Application of USP-NF Standards to Pharmacy Compounding
Bormel Gail
, Valentine Joseph G, Williams Roger L
Sep/Oct 2003
Pg. 361-363

View Sample
Developing Standard Operating Procedures
Allen Loyd V Jr
May/Jun 2002
Pg. 224-225

Is Your Cleanroom Clean? An In-depth Look at Cleaning and Disinfecting Agents, Procedures, and Requirements for the Compounding Pharmacist
Jeffrey Megan
Mar/Apr 2006
Pg. 113-119

Quality Control: Standard Operating Procedures--An Essential Tool for Developing Quality Preparations
Ashworth Lisa D
May/Jun 2007
Pg. 226-229

Obtaining Accreditation by the Pharmacy Compounding Accreditation Board, Part 2: Developing Essential Standard Operating Procedures
Cabaleiro Joe
Sep/Oct 2007
Pg. 397-398

Microbial Air-Sampling Equipment, Part 1: Meeting United States Pharmacopeia Chapter <797> Standards
Kastango Eric S
May/Jun 2008
Pg. 216-229

Tips for Cleanroom Construction and Renovation
Mixon William
, Huffman Lanny
Mar/Apr 2009
Pg. 100-104

Safer Sterile Compounding: Choosing and Using Disinfectants for the Cleanroom
Kastango Eric S
, Douglass Kate, Patel Kedar, Givehchi Babak, Brister Paul, Postlewaite Jay, Taraban Laura
Jan/Feb 2024
Pg. 44-55

Return to Top