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 Validation Documentation
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 Prosthesis Cleaning
6. Users Manual: Proper Drying Avoids Corrosion, Bioburden and Residue
7. Sample 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 here.
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.
Click here 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 email.
To review the TABLE OF CONTENTS of The Aqueous Cleaning Handbook 4th Edition
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
· Consistent manufacturing
· Ingredient disclosures under confidentiality
· Cooperation with audits and quality questionnaires
· Ingredient toxicity data
· Ingredient reactivity information to help determine degradations and interactions
· Cleaner shelf life information
· Residue detection method information
· Residue sampling information
· Acceptance limits information
· Recovery information
· Residue detection methods validation information
· Assistance with written cleaning procedures
4. TECHNICAL LITERATURE: Medical Device Cleaning Validation References. Click here
5. APPLICATION DATABASE: Titanium Prosthesis Cleaning
Titanium prosthetic implantable joints need to be cleaned prior to coating and prior to final cleaning for packaging. Click here to read about how to solve this problem.
For more questions and solutions click here.
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.
7. SAMPLE 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 Critical Cleaning"
30 Glenn St.
White Plains, NY 10603 USA