Equipment Qualification & Thermal Mapping Services


In regulated industries like pharmaceuticals, biotechnology, healthcare, & food processing, ensuring that critical equipment & environments function within defined & qualified parameters is not just a quality requirement—it's a regulatory necessity. At OTSPL, we offer comprehensive Equipment qualification services in India that include thermal qualification services, temperature and RH mapping services, & steam quality test services, all aligned with international standards such as GMP, WHO, USFDA, & MHRA guidelines. Whether it's qualifying an autoclave, mapping a walk-in cold room, or validating shipper boxes & sterilisers, our team ensures every protocol is executed with precision, documented thoroughly, & ready for audit. With the use of calibrated NABL-traceable instruments, validated methodologies, & IQ OQ PQ documentation services, we help clients meet compliance requirements while ensuring operational efficiency & product safety.

Our Equipment Qualification Offerings

We specialise in validation & qualification services, including pharma equipment qualification in India & cleanroom qualification services, delivered by a team of trained engineers using calibrated instruments & validated methodologies.

 

Thermal Qualification Services

We conduct precise thermal qualification services & equipment qualification for:

  • Autoclaves & Steam Sterilisers
  • Dry Heat Sterilisers (DHS)
  • Depyrogenation Tunnels
  • Incubators, Lab Ovens, Muffle Furnaces
  • Vacuum Tray Dryers (VTD), Air Tray Dryers (ATD), Steam Tray Dryers (STD)
  • Process Reactors
  • Refrigerators & Deep Freezers
  • Shipper Boxes, Lyophilizers (Freeze Dryers)
  • Water Baths

All equipment qualifications include Installation Qualification (IQ), Operational Qualification (OQ), & Performance Qualification (PQ), with complete documentation & compliance to GMP, WHO, & FDA standards.

 

Temperature and RH Mapping Services

Oorja provides professional temperature & RH mapping services to ensure uniform environmental conditions for temperature-sensitive operations:

  • Warehouse & Storage Area Mapping
  • Walk-In Cold Room Mapping
  • Temperature-Controlled Vehicle Mapping
  • Shipper Box Qualification
  • Refrigerator & Deep Freezer Mapping

We follow detailed mapping protocols & generate comprehensive reports with time-stamped graphical data, max/min trends, & location-based deviation analysis.

 

Steam Quality Testing Services

To ensure effective sterilisation, we offer pure steam test services & steam quality testing in accordance with EN 285 & HTM standards. Tests include:

  • Non-Condensable Gas (NCG) Test
  • Superheat Test
  • Dryness Value Test

 

These tests verify that steam used in autoclaves & sterilisers meets critical quality parameters for microbial lethality & equipment safety.

 

Ensure regulatory compliance & operational excellence with our comprehensive qualification services. Contact OTSPL today for reliable equipment validation & qualification solutions.