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7 views4 pages

WP Qualify-Disinfectants

Uploaded by

victor
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© © All Rights Reserved
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A WHITE PAPER

SIX STEPS TO
QUALIFYING DISINFECTANTS

By: Deborah Ensign


A WHITE PAPER

SIX STEPS TO QUALIFYING DISINFECTANTS

INTRODUCTION
Sterile pharmaceutical and medical device manufacturing environments require an effective cleaning and disin-
fection program to maintain aseptic conditions and prevent the microbial contamination of the product. The
qualification of the chemical disinfectants used in these environments is extremely important, yet it is often
overlooked. Disinfectant qualifications require more planning, time, and resources than many companies real-
ize. Considering the potential issues and difficulties that could occur while performing these qualifications,
contracting an outside lab experienced in disinfectant qualifications may be the most efficient and least painful
way to perform this work.
The following six steps provide a framework to assist companies in qualifying the disinfectants used in their
environmental cleaning processes. Whether performed internally or by an outside testing lab, they must be
addressed.

STEP 1: DETERMINE THE TEST METHOD


There are a number of methods for qualifying a disinfectant published by the Association of Official Analytical
Chemists (AOAC), yet these are for qualifying the disinfectant itself. They are not appropriate for demonstrating
the efficacy of a disinfectant within the pharmaceutical, biotechnology, and medical device industries.
Two of the most common methods suggested for disinfection qualification in these environments are:
Tube method: This method evaluates disinfectants by inoculating dilutions of the disinfectant and determining
the microbial reduction. It would most commonly be used as a simple screening to determine the type of disin-
fectant most effective against a specific set of organisms before performing a comprehensive disinfectant
qualification.
Coupon method: This method is more comprehensive and uses coupons made from actual facility surfaces.
The surfaces are inoculated and exposed to the disinfectant. The inoculum is then removed from the surfaces
and the log reduction determined.

STEP 2: DETERMINE THE CHALLENGE ORGANISMS


Typically, standard American Type Culture Collection (ATCC) test organisms representing the basic classes of
microorganisms (gram-negative, gram-positive, spore-former, fungus) along with actual environmental isolates
from the client’s facility should be used in the qualification.

STEP 3: DETERMINE THE SURFACE TYPES TO BE TESTED


Each of the construction materials used in the clean room and/or other controlled areas should be tested sepa-
rately. Examples of common materials are stainless steel, glass, plastic, and Plexiglas®. Normally 2-inch by
2-inch square coupons are used for the qualification.
All coupons must be sterilized or disinfected before use in the qualification. Depending on the material, sterili-
zation may be accomplished through steam, ethylene oxide (EO), or chemical methods.

1.
STEP 4: DETERMINE EXPIRATION OF DISINFECTANTS
The qualification should replicate the same disinfectant concentration and contact exposure time used in the
facility. It also should be performed using the worst-case expiration date for each disinfectant. If a container
has a 30-day expiration once opened, and a dilution may be prepared and put into a spray bottle with an expi-
ration of 7 days, the efficacy testing should reflect this.

STEP 5: METHOD VALIDATION


Method validation is a critical step to verify that the testing method allows adequate recovery of the challenge
organisms in the presence of the disinfectants. Regardless of the method being used, the test system must be
inoculated with a low level of challenge organism, with and without (control) exposure to the disinfectant for
the designated contact time.
Typically, the recovery of the challenge organisms should be within a factor of two of the positive controls for
that organism. If the recovery is not satisfactory, the testing method should be repeated using a different neu-
tralization system and/or additional dilutions.

STEP 6: EFFICACY TESTING


Efficacy testing is the actual testing of the disinfectant. Per the USP General Chapter <1072> Disinfectants, the
test system is inoculated with sufficient inoculum to demonstrate at least a two-log reduction for bacterial
spores and a three-log reduction for vegetative bacteria and allowed to dry. The inoculated system is then
exposed to the desired concentration of the disinfectant for the desired contact time.
The surviving population in the test system is determined and the log reduction calculated. The log reduction
data should be used to establish a scientifically supported disinfection program for the client’s facility.

BEYOND THE SIX STEPS


Any time a new disinfectant is introduced into the cleaning process within the facility, a qualification should be
performed. From start to finish, a disinfectant qualification can require from 2 to 12 months to complete. The
timeline will depend on a number of variables, including the number of disinfectants, contact time, and chal-
lenge organisms being tested as well as the number of surfaces (for the coupon method) being evaluated.

2.
About Microtest
Microtest Laboratories is a leader in testing services and contract manufacturing for medical devices, pharmaceuticals, and
biotechnology. It was founded in 1984. The company’s expertise and flexible processes enhance product safety and security, speed
time to market, and minimize supply chain disruption. Mictrotest’s unique single-source capability to provide testing and manufac-
turing solutions allows us to support a full pharmaceutical or medical device product release. Our facilities in Agawam,
Massachusetts, USA include state-of-the-art aseptic manufacturing areas; analytical chemistry, microbiological, and virological
laboratories; Class 100 clean rooms; onsite steam and ethylene oxide sterilization, plus depyrogenation capabilities; purified water
systems; and voice/data systems.

About the Author


Deborah Ensign is supervisor, R&D Lab, at Microtest Laboratories Inc. She has over 20 years of experience in regulatory microbiol-
ogy and contract laboratory operations. Ms. Ensign supervises Microtest’s Specialized Microbiology department. She holds a
bachelor of arts degree in microbiology and is a nationally registered microbiologist. Ms. Ensign oversees all reusable testing
(cleaning, disinfecting, and sterilization) and serves as a resource for USP testing, specifically <51>, <61>, and <62>.

For More Information Contact:


[email protected]
(800) 631-1680
www.microtestlabs.com

1-800-631-1680
1-413-786-1680
fax: 1-413-789-4334

Microtest Laboratories, Inc.


104 Gold St
P.O. Box 848
Agawam, MA 01001

Microtest is a trademark of
Microtest Laboratories, Inc. All other
brands may be trademarks of their
respective holders.

© 2011 Microtest Laboratories, Inc.


All rights reserved.
Printed in USA
1150033 10/11

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