Admonitory Board of trustees for Pharmaceutical Science.


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Sterile Drug Products Produced by Aseptic Processing Draft Concept Paper, Section III. Extension (lines 52-58).
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Slide 1

Counseling Committee for Pharmaceutical Science Sterilization Options Kristen D. Evans Investigative Engineer, USFDA October 22, 2002 10/22/02 OPS Advisory Committee - Aseptic Processing

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Sterile Drug Products Produced by Aseptic Processing Draft Concept Paper, Section III. Scope (lines 52-58) " It is a very much acknowledged rule that sterile medications ought to be made by aseptic preparing just when terminal cleansing is not possible . " [Otherwise,] aide preparing steps (e.g., warm introduction conditions which give some F O ) to expand the level of sterility certainty ought to be considered . "

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Terms PNSU - Probability of a Non-Sterile Unit The likelihood of a unit (item holder) being non-clean after the use of a deadly specialist. PNSU of 1 in 10 6 - the likelihood that a unit is non-sterile is one in a million F O - Sterilization Process Equivalent Time The identical number of minutes at 121.1°C conveyed to a unit by a sanitization procedure. F O = 8 minutes - the cycle conveyed a microbial lethality proportionate to 8 minutes at 121.1°C

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PDA Technical Report #36: Current Practices in the Validation of Aseptic Processing - 2001 At your site, is aseptic handling utilized for items that could be terminally disinfected? For this reaction, "could be terminally cleaned" implies equipped for withstanding a steam cleansing cycle with F O > 8 minutes.

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85% No 67.4% Yes 32.6% 30% (mean) 2% If Yes, then rate of items influenced n = 43 At your site, is aseptic handling utilized for items that could be terminally disinfected? Source: PDA Technical Report #36: Current Practices in the Validation of Aseptic Processing - 2001

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Probability of a Non-Sterile Unit (PNSU) Terminal Sterilization Designed and fit the bill for a PNSU > 1 in 10 6 Generally just a single basic framework to control Aseptic Processing Impossible to experimentally decide a PNSU Many basic frameworks included "Pollution Rate" evaluated with media fills

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Probability of a Non-Sterile Unit Aseptic (Estimated*) versus Terminal Percentage of Firms (n=40) 10 2 10 3 10 4 10 5 10 6 10 7 Probability of a Non-Sterile Unit (1 in … ) * Aseptic preparing PNSU gauges from PDA TR#36, 2001

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Recalls Lack of Sterility Assurance Number of Recalls Fiscal Year Lack of Sterility Assurance is the # 1 purpose behind medication reviews in most recent 5 years Nearly all medications reviewed because of Lack of Sterility Assurance in most recent 20 years were created by means of aseptic handling

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Global Scene European Agency for the Evaluation of Medicinal Products (EMEA) From: Decision Trees for the Selection of Sterilization Methods (10/1999) Terminal Sterilization Fo > 15 minutes "Assistant" Processing Fo > 8 minutes, and PNSU > 1 in 10 6 Aseptic Processing

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Global Scene European Agency for the Evaluation of Medicinal Products (EMEA) " Where a decision is made not to use a technique for terminal cleansing, … legitimate logical clarification and defense ought to be given in the dossier. " Heat lability of a bundling material ought not in itself be considered as sufficient defense for not using terminal disinfection, for generally warm stable items. " From: EMEA Note for Guidance on Development Pharmaceutics (July, 1998)

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Questions for Advisory Committee Should terminal disinfection be utilized when possible? Ought to aide handling be considered with a specific end goal to build trust in aseptically prepared items?

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