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December 2007 – USP revises and releases General Chapter Pharmaceutical Compounding – Sterile Preparations <797> to Tighten Patient Safety Guidance

The U.S. Pharmacopeia announced that changes to General Chapter Pharmaceutical Compounding – Sterile Preparations <797> have been finalized and available online. This revision improves patient safety by tightening standards and conditions for sterile compounding over the current version of USP <797>.

The full chapter is available FREE OF CHARGE by going to the USP website below:

http://www.usp.org/USPNF/pf/generalchapter797.html

These revisions were posted to give the compounding community time to implement changes before they become official. These revisions become official on June 1, 2008 and will be included in USP 32 – NF 27 and the second edition of the Pharmacists’ Pharmacopeia which will be published in March 2008. After June 1, 2008, the current version of USP 31 – NF 26 will no longer be the official chapter.

NIOSH SAFETY ALERT
NIOSH has issued a Safety Alert for Preventing Occupational Exposure to Antineoplastic and other Hazardous Drugs in Healthcare Settings. For additional information: http://www.cdc.gov/niosh/topics/hazdrug/

CETA Certification Guide for Sterile Compounding Facilities CAG-003-2006
On June 7, 2006, the Controlled Environment Testing Association (CETA) has published and released the "CETA Certification Guide for Sterile Compounding Facilities". As an active supporter in CETA, Micro-Clean personnel aided in the review and research process of this important document.

"This guide is to establish an industry-based minimum set of criteria appropriate for performance evaluation and certification of facility and environmental controls used for compounding sterile preparations. It is intended to assist compounders, facilities managers and certification professionals in determining appropriate tests and procedures to be employed on the various engineering controls. This guideline has been established to create a uniform approach for field certifiers to allow consistent and repeatable testing at all facilities." This document is available through http://www.cetainternational.org.

CETA COMPOUNDING ISOLATOR TESTING GUIDE CAG-002-2006
The Controlled Environment Testing Association (CETA) has published and released the “CETA Isolator Testing Guide” (CAG-002-2006). As an active member in CETA, Micro-Clean personnel were intimately involved in the test procedure development, interacting with isolator manufacturers, research support, and review process of this document.

This document provides Compounding Aseptic Isolator users and owners recommended tests that should be provided by the manufacturer of their isolator – thereby verifying that their isolator should meet the sterility and/or containment needs as required in USP Chapter 797 and the 2004 NIOSH Safety Alert “Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings”.

The purpose of this document is to establish an industry-based minimum set of testing criteria appropriate for all Compounding Isolators used pursuant to USP Chapter 797. Compounding Isolators consist of Compounding Aseptic Isolators used for compounding sterile preparations and Compounding Aseptic Containment Isolators used for compounding sterile hazardous drug preparations in pharmacy applications. It is the manufacturer’s responsibility to determine exact testing procedures consistent with these guidelines and assign appropriate values pertaining to acceptance criteria that is consistent with user requirements. This guide has also been established to create a uniform approach for field certifiers to allow consistent and repeatable testing at all facilities.

NEW ISOLATOR APPLICATIONS GUIDE FROM CETA The Controlled Environment Testing Association (CETA) has published and released the “CETA Applications Guide for the use of Compounding Isolators in Compounding Sterile Preparations in Healthcare Facilities” (CAG-001-2005). As an active member in CETA, Micro-Clean personnel were involved in the development, support, and review process of this document. This document is paramount for pharmacists interested in employing Compounding Isolator technology in their Aseptic Compounding practices as part of obtaining or maintaining compliance with USP <797> “Pharmaceutical Compounding – Sterile Preparations”. This document is available through http://www.cetainternational.org.

UPDATE ON NEW AND REVISED IEST DOCUMENTS
"As very active participants in the IEST Working Groups 001, 019, 023 034 (and several more), Micro-Clean is proud to announce that several new publications have been released for publication. These Recommended Practices are published by the Institute of Environmental Sciences and Technology to advance engineering and technical sciences relating to Contamination Control."

These Recommended Practices are available through www.iest.org.

IEST-RP-CC034.2 “HEPA and ULPA Filter Leak Test” ("Required reading" for pharmaceutical and biotechnology organizations)
This expanded Recommended Practice covers definitions, equipment, and procedures for leak testing HEPA and ULPA filters in the factory, at the job site before installation, and as-installed in cleanrooms and in unidirectional-flow, clean-air devices. The document also includes guidelines for selecting the appropriate leak-test method and procedures for measuring the uniformity of the aerosol challenge approaching the filter under test.

IEST-RP-CC001.4 “HEPA AND ULPA FILTERS”
This document covers the basic provisions for HEPA and ULPA filter units for applications requiring extremely high filter efficiency (99.97% or higher) for submicrometer particles. The RP provides performance information for 11 filter types, defines six construction grades, and includes a handy Filter Selection Guide that lists typical applications for each filter type.

IEST-RP-CC019.1 “QUALIFICATIONS FOR ORGANIZATIONS ENGAGED IN THE TESTING AND CERTIFICATION OF CLEANROOMS AND CLEAN-AIR DEVICES”
This Recommended Practice defines recommended qualifications for organizations engaged in the testing and certification of cleanrooms, clean-air devices, HEPA- and ULPA-filtered systems, and associated components. The document also establishes professional categories for personnel performing testing and levels of competence to be demonstrated by the personnel.

IEST-RP-CC023.2: MICROORGANISMS IN CLEANROOMS
This Recommended Practice provides guidelines for the control and quantitative measurement of viable contamination in the air and on surfaces in environments that require control of such contamination. This includes areas designated as aseptic and those considered non sterile. The procedures and techniques employed to achieve the desired level of microbial control are dependent on the level of bioburden that can be tolerated. This RP presents an introduction to the currently accepted methods for bioburden control and environmental monitoring as well as the devices available for the quantification of airborne and surface viable contamination.

This document also describes disinfectants, their lethality spectrum, and techniques for their application.

Animal Lab News CASE STUDY:
Chlorine Dioxide Gas Decontamination of the University of Pennsylvania’s George D. Widener Large Animal Hospital Intensive and Neonatal Care Units
Case Study, Mark A. Czarneski, Paul Lorcheim, Thomas Boyle, Helen Aceto, Barbara Dallap, Donald Munro, Michael A. Regits, and Henry S. Luftman, May/June 2005
"After a salmonellosis outbreak, the 170,000 cubic foot C. Mahlon Kline building remained under quarantine until a successful decontamination program was implemented...
The decontamination process using chlorine dioxide gas was determined to be an unqualified success. Swab tests for Salmonella taken for two months post decontamination produced no positives. The University of Pennsylvania’s C. Mahlon Kline Intensive and Neonatal Care Units was lifted from quarantine and declared fully operational."

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