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Validating Pharmaceutical Cleanrooms for Sterile Manufacturing

Pharmaceutical cleanroom validation is essential to confirm that controlled environments comply with strict regulations for sterile drug production.

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Validating Pharmaceutical Cleanrooms for Sterile Manufacturing

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  1. WHAT IS THE ISO STANDARD FOR CLEAN ROOM VALIDATION?

  2. Multiple sectors are vulnerable to contaminants. To encourage industries with precision in cleanlines, the ISO standard for cleanroom validation is introduced. Sectors like pharmaceuticals, biotech, and aerospace, where even a minute dust particle can create chaos. Cleanroom validation is standardized to maintain product quality and ensure a controlled environment. These internationally recognized standards ensure quality standards and confirm the efficacy of the product.

  3. Understanding Cleanroom Validation • It is a documented process to ensure everyone is on the same page. Designed to check if the room is maintaining the standards for airborne particles, microbes, and airflow. However, cleanroom validation is not a one-time deal. • You need to make periodic revelations to ensure the room is abiding by the ISO standard for cleanroom validation. This helps to uphold the quality standards and identify any slip-ups. Further aid to reduce stress with non-compliance and helps with product integrity.

  4. Key Parts of ISO 14644: • ISO Class 1 Max 10 particles of 0.1 µm per cubic meter. Used for cutting-edge tech where a single particle needs gentle care. • ISO Class 5 Allows 3,520 particles of 0.5 µm. Common in pharmaceutical cleanroom validation for sterile drug production. • ISO Class 7 Up to 352,000 particles of 0.5 µm. Often a background area for less critical pharma processes.

  5. ISO 14644-1: CLASSIFICATION OF AIR CLEANLINESS • Confirms the precision of cleanliness, with the concentration of airborne particles. • Validates methods for measuring and confirming particle counts.

  6. ISO 14644-2: MONITORING TO PROVIDE EVIDENCE OF CLEANROOM PERFORMANCE Presentations are tools that can be used as lectures. Requires periodic testing to demonstrate ongoing compliance. Check on maintaining compliance. • ISO 14644-2: MONITORINGTOPROVIDE EVIDENCEOF CLEANROOMPERFORMANCE Clarifies detailed testing procedures to confirm with the ISO standard for cleanroom validation. Covers airflow visualization, filter leakage, recovery time, and more. • ISO 14644-3: TEST METHODS

  7. Installation Qualification (IQ) • Making sure the cleanroom’s built right—HVAC, filters, walls, everything. HOW CLEANROOM VALIDATION WORKS • Operational Qualification (OQ) • Running a quality check on the empty cleanroom with equipment only. It checks on its performance corresponding to the design. • Performance Qualification (PQ) Put to the test at the current time in the presence of workers, and machinery running. It checks its tolerance to cope with the turmoil.

  8. ISO 14644 IN PHARMA CLEANROOMS ISO Class 5 ISO Class 7 This standardization takes care of the microbial counts and super-low particles. Background areas supporting aseptic zones, less stringent but still tightly controlled.

  9. PHARMACEUTICAL CLEANROOM VALIDATION UNDER ISO 14644 MEANS: • Particle Counting: Confirms particle quantity through laser particle counters. Monitor adherence to the ISO class. • Airflow Checks: Block the presence of contaminants in critical areas through laminar and turbulent airflow. • Pressure Differentials: Regulate pressure to prevent the dirty air from contaminating the room. • Microbial Sampling: Check on surfaces and test the air to spot the presence of any bacteria or fungi. • HEPA Filter Testing: Helps to check for leaks that could be an entryway for harmful particles.

  10. TO STAND BY CLEANROOM VALIDATION AND ISO 14644: • Write a Validation Master Plan: Map out every step. Gain clarification with the key stakeholders and timeline. • Use Good Gear: Employ high-quality particle counters. Invest in trusted samplers only. • Train Your People: Introduce the practice of protective clothing as a non-negotiable routine. Sloppy gowning or an ill-mannered attitude can bring consequences. • Monitor Constantly: Appoint workers for constant monitoring. This is essential to catch real-time issues and save energy. • Document is a must: keep up-to-date documentation for each step to ensure compliance.

  11. NEED EXPERT GUIDANCE ON ISO 14644 COMPLIANCE? • The ISO standard for cleanroom validation, led by ISO 14644, is the gold standard for maintaining adherence to cleanrooms. At PDVD consultant, we offer a comprehensive Turnkey Solution Encompassing Pharmaceutical Facility Planning, Design, Validation and documentation. We understand the importance of product integrity.

  12. THANK YOU Phone No. : +91 84691 49494 Email : info@pd-vd.com Website : https://pd-vd.com/

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