Airocal is a leading specialist provider of validation services. We have grown as a reputable company and offer our services nationally & internationally. As an industry leader we are having more than 15 years / nearly a decade of experience using both thermocouples and thermistors.
The pharmaceutical industry is a highly regulated environment based on research, evidence, record-keeping and validation. Our experience and expertise will give you a clear, compliant and transparent validation package.

The term "Thermal validation" is the process of validating / qualifying equipment and storage facilities to prove that they will create and maintain the temperatures they are designed for.

Our range of bespoke services to the pharmaceutical, biotechnology and healthcare industries. We specialise in the validation of international standards as per WHO TRS 961, ISO/IEC:60068, HTM 2010

Validation and Monitoring equipment (Wired & Wireless) are major responsibilities comes under thermal validation. Well maintained and calibrated equipment ensures that it operates at peak performance and complies with regulatory requirements.



Stability chambers are ideal for testing storage, shelf life, packaging and stability. Stability chambers are available in temperature only or with temperature and humidity. Sizes range from reach-in to walk-in and most chambers feature a temperature range of -20° C to 60° C and an optional humidity range from 10% to 95% RH. Stress testing is likely to be carried out on a single batch of the drug substance. It should include the effect of temperatures in 10° C increments (50° C, 60° C, etc.). Increments may be greater for accelerated testing. Stress testing for humidity typically is performed at 75% RH or greater (where appropriate). Other tests can include effects of oxidation and photolysis. Stress testing of the drug substance can help identify the likely degradation products, which can in turn help establish the degradation pathways and the intrinsic stability of the molecule. It can also validate the stability indicating power of the analytical procedures used. The nature of the stress testing will depend on the individual drug substance and the type of drug product involved.

Dry heat sterilization (or Depyrogenation) is a process aimed at the reduction in the level of pyrogens with the use of hot air in temperature ranging from 160° C up to 400° C. The temperature used depends on the duration of the process. Gravity or mechanical heat convection can be used for this process. The former uses the natural interaction between air and different temperatures and the latter produces a specific flow of air with the help of a blower. Depyrogenation is mainly used in the sterilization of vials for aseptic filling. The process is also useful to sterilize assembled and packaged materials, since heat conduction does not require the contact of the product with steam or water. However, not all products can withstand the high temperatures required for this kind of process (e.g. metal goods, heat sensitive solutions, etc.).Batch and dynamic are the two main techniques for depyrogenation. Batch production is usually done in static ovens where the product is placed in metal crates and exposed to high temperatures. Dynamic involves the use of a depyrogenation tunnel, where goods are transported over a continuous band through different heating zones of the tunnel.


We conduct validation tests that include Temperature and Humidity Measurements / Tests. Two levels of temperature and humidity tests are used by us depending on the requirement. In the first level, general temperature and humidity uniformity are tested. The general level test is used to ensure that the clean room's HVAC system maintains the specified levels of temperature and humidity required for occupant comfort. The second level or the comprehensive level test identified that the clean room HVAC systems needs to maintain the specified levels of temperature and humidity required for both occupant comfort and process temperature control.



Components and products. Dry heat sterilization is often used for heat-stable oils, ointments and powders. Most often, depyrogenation of parenteral containers is performed utilizing a dry heat oven. The depyrogenation process is also utilized on certain heat-stabile components, glass containers, metal equipment, etc. to render the item and final parenteral product free of pyrogens. The equipment utilized to provide the dry heat medium must be validated to ensure that the system is able to provide sterile and/or depyrogenated components, on a reproducible basis. The validation of a dry heat sterilization and depyrogenation process involves approaches and procedures which parallel those utilized for steam sterilization. The efficiency of any heat treatment is determined by the design and source of the heat. Hot air is substantially less efficient in a thermal transfer medium as compared to steam. The validation effort must include heat distribution, heat penetration, bioburden and pyroburden determination, filter integrity and microbial/endotoxin challenges.


Freeze drying (or lyophilization) is a technique used to remove water from a solution to leave a dry ‘cake’ as an end product. The dry product is much more stable than a solution. The reduced weight and volume is a big advantage and the removal of the water does not change the activity of the product. This technique involves freezing the product on a shelf using extremely low temperatures (typically –40 to –50°C), applying a vacuum and then slowly heating the product to ensure the ice turns into vapor. This removes the water content from product by a process called sublimation.

The critical parameters during freeze-drying are temperature (product and shelf) and pressure/Vacuum. These measurements are usually recorded with every cycle to determine when the product is dry. In addition to monitoring each cycle, freeze driers also require regular validation. This will generally involve temperature mapping of the shelves in the chamber, condenser cool down test, system evaluation test (Vacuum Pull-Down) to test Vacuum pumping system efficiency and Vacuum integrity test to show quality of seals, as well as validation of steam supplies for the SIP system.

As freeze drying is a rather expensive process most products being processed are within the pharmaceutical and biotechnology industries. Companies often use freeze-drying to increase the shelf life of products, such as vaccines and other injectables. By removing the water from the material and sealing the material in a vial, the material can be easily stored, shipped and later reconstituted to its original form for injection.

Lyophilization can also be performed in other industries like: Food industry (example: freeze dried fruits, astronaut food supplies, instant coffee)

Technological industry:
• In chemical synthesis to make them more stable, or easier to dissolve in water for subsequent use
• In bioseparations as a late-stage purification procedure to remove solvents

In bacteriology to conserve special strains

Conservation and preservation industry:
• Flowers
• AnimalsWater damaged books and documents


Temperature Uniformity Surveys commonly referred to as a TUS, establish objective evidence of the heat distribution characteristics throughout an oven or furnace system. It also identifies the qualified work zone within the oven or furnace system. TUS's can also be an effective way of determining the efficiency of the furnace system and to monitor furnace performance over time.

System Accuracy Test, commonly referred to as an SAT, is another critically important and often required test. System Accuracy Tests are performed to determine the error within the temperature control system (temperature control device/lead wire/thermocouple). Regardless of the application, knowing the error that exists in your temperature control system allows for more consistent control of quality.