PRIME SYSTEMS
PHARMACEUTICAL VALIDATION & ENGINEERING • EST. 2004

Precision Validation for Regulated Pharma Manufacturing

Providing full-scope qualification, cleanroom environmental validation, thermal mapping, and critical utilities verification strictly complying with WHO, ISO 14644, MCC, and cGMP international standards.

20+
Years of Excellence
100+
Facilities Validated
10+
Top Pharma Clients
100%
cGMP & WHO Compliance

Trusted by Leading Global & National Pharmaceutical Manufacturers

Pfizer
GlaxoSmithKline (GSK)
Bosch Pharmaceuticals
The Searle Company
Sami Pharmaceuticals
AGP Pharma
Atco Laboratories
Lucky Core Industries (ICI Pakistan)
Indus Pharma
Linz Pharmaceuticals
Pfizer
GlaxoSmithKline (GSK)
Bosch Pharmaceuticals
The Searle Company
Sami Pharmaceuticals
AGP Pharma
Atco Laboratories
Lucky Core Industries (ICI Pakistan)
Indus Pharma
Linz Pharmaceuticals

Uncompromising Compliance for Regulated Industries

Established in 2004, Prime Systems has evolved into one of Pakistan's most respected validation and technical engineering consultancies. We assist multinational and domestic pharmaceutical companies in achieving seamless audit readiness and high-grade cGMP compliance.

All protocols, testing procedures, and qualification packages developed by Prime Systems strictly adhere to the world's most stringent regulatory standards, ensuring your facilities, machinery, and utilities meet both local and international export audit benchmarks.

WHO TRS Guidelines
ISO 14644 Cleanroom Classifications
MCC South Africa
EU cGMP Annex 1
ISO 8573 Compressed Air
View All Technical Protocols
Executive Leadership

Asim Hyderi

Founder & Principal Validation Consultant

"All efforts at Prime Systems are focused on delivering rigorous, audit-ready validation that enables pharmaceutical manufacturers to achieve uncompromised compliance in a cost-effective, dependable manner."

B.E. Mechanical Engineering — N.E.D. University
Former Head of Engineering in Multinational Pharma (10+ Years)
30+ Years Overall Pharma Engineering & Validation Experience
Specialist in WHO, MCC, ISO & Corporate Multinational Standards

Our Core Validation Domains

Comprehensive qualification solutions tailored to sterile, oral solid dosage, and biotechnology manufacturing plants.

HVAC & Cleanroom Environmental Validation

Complete qualification and certification of HVAC systems and controlled environments in compliance with ISO 14644 and cGMP regulations.

  • Air Balancing & Airflow Measurement (Capture Hoods & Anemometers)
  • HEPA Filter Integrity Testing (Aerosol Photometer & Generator)
  • Room Differential Pressure Balancing & Room Clean-up Recovery
  • Airborne Particle Counts (ISO 14644-1 Classes 5 through 8)
  • Airflow Pattern Visualization (Smoke Studies with Video Documentation)
Explore Cleanroom Services

Thermal Validation & Mapping

Precise thermal qualification of critical sterilization equipment and temperature/humidity mapping of controlled storage zones.

  • Autoclaves & Super-Heated Water Sterilizers
  • Dry Heat Sterilizers & Depyrogenation Tunnels
  • Cold Storage Rooms (2–8°C) & Deep Freezers (-20°C)
  • Systematic Warehouse Temperature Mapping
Explore Thermal Protocols

Pharma Equipment Qualification

Standardized lifecycle qualification documentation (DQ, IQ, OQ, PQ) for primary and secondary production machinery.

  • Design Qualification (DQ) Verification
  • Installation Qualification (IQ) Protocol & Execution
  • Operational Qualification (OQ) Parameter Testing
  • Performance Qualification (PQ) Batch Verification
Explore Equipment DQ-PQ

Critical Utilities Validation

Verification of clean manufacturing utilities ensuring uninterrupted compliance, purity, and safety throughout the production cycle.

  • Compressed Air Systems Testing (ISO 8573 Moisture, Oil & Particulates)
  • Boiler & Clean Steam Quality Testing (Non-condensable Gases & Dryness)
  • Purified Water Generation, Storage & Distribution Loops (USP/EP Standards)
Explore Utilities Validation

Precision Instruments & Equipment

Our field tests are executed exclusively with state-of-the-art, NIST-traceable calibrated instruments to guarantee verifiable audit accuracy.

Cleanroom
Aerosol Photometer

Aerosol Photometer

Used for in-situ leak detection and integrity testing of installed HEPA filters.

Cleanroom
Aerosol Generator

Aerosol Generator

Generates poly-dispersed PAO/DOP aerosol challenge for HEPA filter efficiency testing.

Cleanroom
Laser Particle Counter

Handheld Laser Particle Counter

High-precision optical counter for measuring airborne particulate concentrations per ISO 14644-1.

Cleanroom
Air Flow Capture Hood

Air Flow Capture Hood

Direct volumetric airflow measurement for air balancing and room air changes per hour (ACPH).

Cleanroom
Air Velocity Meter

Air Velocity Meter (Anemometer)

Measures laminar flow face velocity across clean workbenches, biosafety cabinets, and LAF hoods.

Thermal
Multichannel Thermocouple Logger

PC-Based Multichannel Logger

Real-time multi-point temperature data acquisition for sterilizers, autoclaves, and dry heat tunnels.

Thermal
Temperature and Humidity Datalogger

Temperature & RH Dataloggers

Multi-zone mapping of stability chambers, incubators, cold rooms (2–8°C), and warehouses.

Thermal
Temperature Datalogger

Compact Temperature Dataloggers

Autonomous high-accuracy sensors for continuous thermal profile monitoring in confined storage.

Pressure
Digital Manometer

Digital Differential Manometer

Measures room pressure cascades, HEPA filter resistance, and cleanroom enclosure integrity.

Speak Directly with our Senior Engineers

Whether you require urgent audit readiness, annual cleanroom certification, autoclave re-qualification, or complete plant validation, connect directly with our engineering consultants for immediate guidance.

Instant WhatsApp Chat

Connect immediately on WhatsApp to share protocols, floor layouts, or schedule upcoming shutdown testing.

Direct Phone Call

Speak directly with Principal Consultant Asim Hyderi for immediate technical discussion and plant consultations.

Official Technical Email

Send formal RFQs, vendor qualification dossiers, URS documentation, or plant validation proposals.

Engineering Head Office

Block 13-A, Gulshan-e-Iqbal, Karachi, Pakistan

Strict NDA Confidentiality Rapid 24-Hour Response Audit-Ready Documentation