Medical Device Manufacturing

qvtest Medical Device Manufacturing

Facilities and Utilities Qualification by QV Test – Total Validation for Cleanroom

The manufacturing of medical devices is one of the most highly regulated sectors under FDA and ISO standards, as product safety directly affects patient health.
Contamination from chemical residues or impurities can lead to severe infection or complications in end users.

To ensure safety and compliance, medical devices are categorized into three classes (Class I, II, and III) — based on the level of risk associated with device failure.
Regardless of classification, every device must comply with FDA, GMP, and ISO regulations throughout the manufacturing and validation process.

Facilities and Utilities Qualification

In medical device facilities, qualification studies are required for critical utilities — systems that directly contact the product or have potential to impact product quality.
Typical examples include:

  • Purified Water Systems
  • Clean Steam Systems used for sanitizing product containers or vessels
  • Compressed Air and Process Gases that contact the product

QV Test provides full IQ/OQ/PQ qualification and documentation in accordance with ISO 13485, ISO 14644, and FDA guidelines to ensure that your utilities consistently perform within specified acceptance criteria.

Cleanroom Validation

A controlled cleanroom environment plays a vital role in maintaining the sterility and quality of medical devices.
QV Test’s validation service ensures that cleanroom performance complies with ISO 14644 and NEBB procedural standards, demonstrating that:

  • Supplied air is sufficient to remove generated contamination.
  • Air quality does not introduce additional particulates.
  • Airflow direction moves from clean to less-clean zones.
  • Air movement prevents accumulation of contamination.

QV Test Offers:

Primary Tests (ISO 14644):

  • Airflow Velocity & Uniformity Tests
  • Airflow Volume & Air Change Rate (ACH) Tests
  • HEPA Filter Installation Leak Tests
  • Airborne Particle Count & Cleanliness Classification Tests
  • Room Pressurization Tests

Secondary Tests (Optional):

  • Airflow Smoke Pattern Visualization
  • Recovery Tests
  • Lighting Level & Uniformity Tests
  • Temperature & Humidity Uniformity Tests

HVAC System Qualification – Air Handling Unit (AHU)

The HVAC system supporting a cleanroom must be validated to ensure it maintains pressure differentials, temperature, and humidity as per design.

QV Test Provides:

  • Airflow Velocity & Uniformity Tests
  • HEPA Filter Leak Tests
  • Magnehelic Gauge Verification
  • IQ/OQ Documentation and Execution

Dust Collector System Validation

The dust collection system prevents airborne contaminants from re-entering the production area.
Validation includes studying airflow velocity and direction, smoke pattern, and pressure measurement to ensure safe exhaust and containment.

QV Test Offers:

  • Airflow Velocity & Uniformity Tests
  • HEPA Filter Leak Tests
  • Room Pressurization & Smoke Pattern Tests

Environmental Control Unit Validation

(Cold Room, Stability Chamber, Incubator, Cool Storage, Warehouse)

Temperature and humidity must remain within specified limits under both normal and extreme conditions.
QV Test performs Temperature & Humidity Mapping Studies to identify hot spots, cold spots, and recovery time during excursions.

Service Includes:

  • Temperature Mapping Studies
  • Temperature & Humidity Mapping Studies

Equipment Qualification

Laminar Airflow Unit

A laminar airflow cabinet maintains a unidirectional flow to minimize contamination risk.
Validation ensures clean air quality and pressure balance consistent with Class A / ISO Class 5 environments.

QV Test Performs:

  • Airflow Velocity & Uniformity Tests
  • HEPA Filter Leak Tests
  • Airborne Particle Count Tests
  • Differential Pressure & Magnehelic Gauge Reading
  • Airflow Smoke Pattern Tests

Biosafety Cabinet (BSC)

To protect operators and products from biological contamination, BSC validation is conducted per GMP and NSF49 standards.

Test Parameters Include:

  • Airflow Velocity & Uniformity Tests
  • HEPA Filter Leak Tests
  • Airborne Particle Count Tests
  • Differential Pressure & Smoke Pattern
  • Lighting & UV Intensity Tests

ETO Sterilizer Validation

Ethylene Oxide (ETO) sterilization is used for heat- and moisture-sensitive medical devices such as plastic components or electronics.
Validation focuses on temperature and humidity distribution within the chamber and product load to ensure uniform sterilization.

QV Test Provides:

  • Temperature & Humidity Mapping Studies
  • Cycle Performance Qualification

Why Choose QV Test

With extensive technical expertise, regulatory knowledge, and accredited testing capabilities,
QV Test ensures your facilities, cleanrooms, and utilities operate in full compliance with international standards — supporting your path toward safe, effective, and audit-ready medical device manufacturing.

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