Standard

ISPE ISPE Good Practice Guide: SMEPAC - Standardized Methodology for the Evaluation of Pharma Airborne Particle Emissions from Containment Systems 3rd Edition

Published

Note: This standard has a new edition: ISPE ISPE Good Practice Guide: Control Strategy Development for Continuous Manufacturing of Oral Solid Dosage Forms

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Abstract

This Guide was originally titled ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment.As in previous editions, this Guide provides principles and standardized methodologies for evaluating the containment capability of equipment used in the pharmaceutical industry under specific, defined conditions. The methodologies include sampling and analysis for airborne emissions and surface deposition of surrogate material processed within the equipment following defined test protocols. These methodologies reflect pragmatic good industrial/occupational hygiene practice.The Guide has been revised to include complex equipment systems, such as continuous manufacturing equipment and processes, and additional information on surrogate selection. The analysis and interpretation of data has been expanded, along with new test protocols and updates to existing ones.This new edition incorporates the lessons learned from numerous containment performance assessments conducted by pharmaceutical industry professionals following the criteria outlined in the Guide. It serves as a tool to be used in conjunction with other industry guides. Intended to have global application, it has been developed to meet the needs of equipment suppliers and users.This the third edition has a new title that reflects what the industry has long referred to as ISPE’s “SMEPAC” Guide.

Document information

  • Standard from ISPE
  • Published:
  • Edition: 3rd
  • Version: 0
  • Document type: IS

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