Nonmembers- Purchase your copy today at the PDA Bookstore
For a limited time only, PDA Technical Report No. 30 Revised 2012: Parametric Release of Pharmaceuticals and Medical Device Products Terminally Sterilized by Moist Heat is available for free download to PDA members by June 15th.
This latest report provides current demonstrated best practices of this sterile product release method with an emphasis on use of science-based approaches during the development of a parametric release program for pharmaceutical and medical device products terminally sterilized by moist heat.
The original report was groundbreaking in that it espoused a rational solution to the problem of the sterility test. Since 1999, many regulatory agencies and pharmacopoeial organizations across the globe have recognized the use parametric release and have fostered its implementation through the development of supporting standards, guidances and recommended practices. This growing adoption of parametric release necessitated an update to the 1999 report.
PDA Members - How to download Technical Report No. 30 Revised 2012 by June 15th.
1. Click this link to go to PDA's Bookstore: Technical Report No. 30 Revised 2012.
2. Please log in with your PDA ID number and password. The login button is located at the top right corner of the page.
3. Once you have logged in and verified that the correct price is displayed, click "Add to Cart".
4. When you are ready to complete your order click "Check Out". You will be prompted to confirm your shipping details. Proceed by clicking "Next Step".
5. Your order confirmation will appear on the next page. Click "Download Your Purchases" below the Item Description on your confirmation to begin your download.
6. Click on the product you would like to download. You will be asked to Open or Save the document; PDA recommends that you immediately save the document to your computer. Each time you open the document you will be prompted to provide your PDA password. The document password is the same as your PDA password at the time of your download and cannot be changed.
If you have any questions or need further assistance, please contact the PDA membership department.
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