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Subject: Alconox Cleaning Info, Validation Report and Vendor Criteria
Alconox Cleaning Info
September 2006 Vol 9 No. 1
The Newsletter of cGMP and Cleaning Process Validation
TABLE OF CONTENTS
1. Introduction: Supporting
2. Free Book Offer: The
Aqueous Cleaning Handbook 4th Edition
3. Book Excerpt: Cleaning
Validation Final Report and Vendor Criteria
4. Literature: Medical Device
Cleaning Validation References
5. Application Database: Titanium
6. Users Manual: Proper Drying
Avoids Corrosion, Bioburden and Residue
Offer: Questionnaire and Detergent Sample Selection
Welcome to Alconox Cleaning Info,
the newsletter of cGMP and cleaning process validation.
At Alconox we believe that knowledgeable customers are successful
customers. Our dedicated technical
support team works to assist you in selecting and validating a detergent for
your Medical Device manufacturing needs. The
necessary supporting documentation required for validation records includes
Certificate of Analysis, MSDS, Technical Bulletins, Trace Analysis Certificate
and Inhibitory Residue Tests are available by clicking
2. FREE BOOK OFFER: The
Aqueous Cleaning Handbook 4th Edition, a $39.95 value!
This 182 page hardcover book reviews a range of critical-cleaning topics
including an in depth discussion on cleaning validation and has a comprehensive
index and glossary of key terms.
to request your free copy. Please ENTER
your Name, Title, Company, Street, City, State, Zip code and any
additional information concerning your cleaning needs into the body of the
To review the TABLE OF CONTENTS of The
Aqueous Cleaning Handbook 4th Edition Click
3. BOOK EXCERPT: Cleaning Validation Final Report and Vendor
Criteria, The Aqueous Cleaning Handbook 4th
Edition, Chapter 8, Page116-117
In the final report the next section would deal with
cleaning process design. It should
include references to standard operating procedures and how they were evaluated.
Next, include section of data analysis that provides statistical justification
for the conclusions reached. A
defined procedure for changing validated processes is necessary.
It should describe approval and review processes required when making
specific changes. Provisions for emergency changes should be made. There
should also be a list of assumptions made, to be reviewed whenever anything is
changed (eg..hardest to clean or most toxic).
Include a review of validated processes during the annual product review
(APR). Use it as an opportunity to determine whether all the minor changes made,
since the previous review do not amount to significant changes that exceed the
assumptions made and require a revalidation. Typically a revalidation is
required when the cleaner has been changed.
It may be appropriate to continue an old cleaning operation while phasing
in a new one. Monitor the new process to prove that it produces the same
validated results as the old one.
The final section of the final validation report would have
the references to any standard methods, journal articles, or government
In selecting an aqueous cleaner
for GMP manufacturing, where a cleaning validation is required, consider both
the efficacy of the cleaner and the ability of the cleaner manufacturer to
support your validation efforts. What to look for from a cleaner manufacturer:
Lot traceability of the cleaners
Certificates of Analysis for the cleaners
Ingredient disclosures under confidentiality
Cooperation with audits and quality questionnaires
Ingredient toxicity data
Ingredient reactivity information to help determine degradations
Cleaner shelf life information
Residue detection method information
Residue sampling information
Acceptance limits information
Residue detection methods validation information
Assistance with written cleaning procedures
4. TECHNICAL LITERATURE: Medical
Device Cleaning Validation References. Click
5. APPLICATION DATABASE: Titanium
Titanium prosthetic implantable joints need to be cleaned prior to coating
and prior to final cleaning for packaging.
here to read about how to solve this problem.
For more questions and solutions click
6. USER'S MANUAL: Proper Rinsing
Avoids Contamination and Water Spots
The wrong rinse procedure or type of rinse water can cause incomplete
cleaning or leave water spots. Click
here to learn about proper rinsing procedures and the differences between
rinsing with tap water, deionized water, distilled water, water-for-injection
and reverse-osmosis water.
OFFER: Questionnaire and Detergent Sample Selection
Click here to
fill out a short questionnaire; an appropriate detergent sample will be selected
to meet your cleaning needs and mailed to you!
Published by AL Technical Communications, LLC for:
Alconox, Inc. "The Leader in
30 Glenn St.
White Plains, NY 10603 USA