Revised August 27 2013 DOP PAO HEPA IntegrityTesting Procedure

                                               
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DOP Testing Procedure - Air Techniques International

                                               
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DOP Testing Procedure - EACO / dop-testing-procedure-eaco.pdf / PDF4PRO

                                               
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What is DOP Testing for HEPA Filters and What Does it Involve?

                                               
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DOP Testing Procedure - EACO / dop-testing-procedure-eaco.pdf / PDF4PRO

                                               
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  • What are the objectives of the guideline on stability testing?
  • 1.1. Objectives of the Guideline The following guideline is an extension of the Guideline on Stability testing of New Veterinary Drug Substances and Medicinal Products (EMEA/CVMP/VICH/899/99-Rev.1) and sets out the stability testing requirements for existing active substances and related finished products.
  • What is a DOP test?
  • DOP testing is a very quick process that tests the integrity of the HEPA (High Efficiency Particulate Air) filter using Dioctyl Phthalate (DOP liquid) in it's operational condition.
  • What is a stability study?
  • The purpose of the stability study is to establish, based on testing a minimum of two or three batches of the finished product, a shelf life and label storage instructions applicable to all future batches of the finished product manufactured and packaged under similar circumstances.
  • What should be included in a stability study for a finished product?
  • The use of terms such as “ambient conditions” or “room temperature” is unacceptable. 2.2. Finished Product 2.2.1. General The design of the formal stability studies for the finished product should be based on knowledge of the behaviour and properties of the active substance and the dosage form.
  • What should I do if I have a DOP problem?
  • It requires specialized equipment and qualified professionals with experience. Do not put DOP testing off. Make sure you have a regular program of testing in place. Request an early test if there are any causes for concern. In the meantime check out some other products you will find helpful in this industry.
  • What should be included in a stability study?
  • Stability studies should include testing of those attributes of the finished product that are susceptible to change during storage and are likely to influence quality, safety and/or efficacy.