Clean Room Validation Training & Certification Course

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Overview

For Pharmaceuticals, Molecular Biology Labs, BSL-III Labs & Operations Theatres

Clean room validation is the process of verifying and documenting that a controlled environment consistently performs according to its intended design specifications and regulatory requirements.

It ensures that critical environmental parameters such as airflow, temperature, humidity, differential pressure, particle concentration, air change rate, and HEPA filter performance are maintained within prescribed limits.

This process is highly critical in pharmaceutical manufacturing, medical device production, hospitals, research laboratories, electronics manufacturing, and biological safety laboratories, where contamination control directly impacts product quality, patient safety, and regulatory compliance.

FARE Labs, an NABL-accredited laboratory as per ISO/IEC 17025, offers Clean Room Validation Training & Certification Course for freshers and professionals, with practical exposure to testing methodologies, calculations, compliance requirements, and report preparation.

Course Objectives

Training on clean room validation principles and testing methods covering the following areas:

  • Importance of clean room validation
  • Need and application in pharmaceutical and healthcare sectors
  • Regulatory requirements and standards
  • Environmental control and contamination prevention
  • HEPA filter performance evaluation
  • Airflow and pressure validation
  • Particle monitoring techniques
  • HVAC performance verification
  • Sampling location calculations
  • Air changes per hour (ACPH) calculations
  • Hands-on use of instruments
  • Report preparation and compliance documentation
  • NABL / NABH / GMP compliance requirements

What is to learn?

  1. Introduction to Clean Room Validation
  • Purpose of clean room validation
  • Design specification verification
  • Environmental control principles
  • Contamination control strategies
  • HVAC system effectiveness
  • Product and personnel safety
  • Clean room classifications (Class A, B, C & D)
  • Regulatory compliance standards

Including:

  • ISO 14644
  • GMP / CGMP
  • USFDA
  • NABL / NABH
  • EN 12469
  • EN 1822
  • NSF / ANSI 49
  1. Parameters to be tested

Participants will be trained on testing of the following parameters:

  • Particle Monitoring Test
  • HEPA Filter Integrity Test
  • Air Changes Rate
  • Air Visualization / Smoke Pattern Test
  • Differential Pressure Test
  • Temperature & Humidity Test
  • Recovery Test
  • Light Intensity Test
  • Noise Intensity Test

Testing frequency requirements will also be covered as per standards.

  1. Separate Devices (HEPA Equipped)

Hands-on validation training on:

  • Bio Safety Cabinet
  • Laminar Air Flow Cabinet (Horizontal & Vertical)
  • Dynamic Pass Box
  • Sterile Dress Cabinet
  • Hanging LAF
  • Sampling Booth
  • Dispensing Booth
  • PCR Cabinet

Validation parameters for these systems include:

  • Particle count
  • HEPA integrity
  • Airflow pattern
  • Pressure differential
  • Recovery time
  • Light and noise intensity
  1. Method Development & Calculations

Special practical module on important validation calculations:

Sampling Locations

For large clean rooms and clean zones

  • Number of sampling locations
  • Area-based location calculations

Sampling Volume

Minimum sample volume per location calculations

CFM Calculation

Using duct / grill area and average air velocity

ACPH (Air Changes per hour)

Calculation based on room volume and airflow

Acceptance Criteria

Interpretation based on ISO / GMP standards

Trend Analysis

Deviation tracking and report interpretation

 

  1. Operation Theatre (OT) Validation

Special module for Hospital OT Validation as per NABH Guidelines

Purpose

To verify indoor air quality and patient safety as per ISO 14644 and NABH standards

Types of OT

  • Type A
    Super Specialty OT
    (Neurosciences, Joint Replacement, Cardiac, Transplant)
  • Type B
    General OT
    (Ophthalmology, Day-care, Basic Surgical Disciplines)

Parameters Covered

  • Air changes per hour
  • Air velocity
  • Pressure differential
  • Air particulate count
  • Temperature & humidity
  • HEPA filter integrity
  1. Instrumentation and Setup

Hands-on practical exposure using:

  • Aerosol Photometer
  • Particle Counter
  • DOP / PAO Generator
  • Air Velocity Meter / Anemometer
  • Differential Pressure Meter
  • Lux Meter
  • Sound Level Meter
  • Temperature & Humidity Meter
  1. Industries / Sectors Served

This training is highly beneficial for:

  • Pharmaceutical Industries
  • Hospitals / Healthcare Facilities
  • Research Laboratories
  • Molecular Biology Labs
  • BSL-II / BSL-III Labs
  • Medical Device Manufacturers
  • Food Industries
  • Electronics / Semiconductor Industry
  • HVAC Validation Companies
  • Clean Room Consultants

Participants will receive real-time practical exposure for:

  • Clean room validation
  • OT validation
  • HEPA filter testing
  • Smoke pattern testing
  • Particle count studies
  • Compliance documentation
  • NABL / NABH audit preparation

Designation: Clean Room Validation Trainee
Section: Training
Qualification: B.Tech / M.Tech / Diploma / B.Sc / M.Sc
Experience: Fresher / Professionals

Fees: As per industry standards
Duration: Short Term / Long Term
Location: Gurugram, Haryana

  • NABL-accredited laboratory
  • ISO/IEC 17025 compliant testing
  • National traceability standards
  • Advanced testing instruments
  • Expert practical guidance
  • Detailed compliance reporting
  • Industry-recognized certification
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