01 Nov Thermal Qualification
GN Engineer Services 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.
We are specialises in the qualification of the following equipment:
- Autoclave / Sterilizer Qualification
- Cold rooms, Warehouse and Room Mapping
- Depyrogenation Ovens Qualification
- Lyophilizers Qualification
- Depyrogenation Tunnels
- BOD, Deep Freezers / Walk In Freezers
- Photostability Chember Qualification
- Steam-in-Place Qualification
- Stability Cabinets
- Washer Disinfectors
- CIP Systems
- Dry Heat Ovens
- SIP Systems
- Ultra Low Freezers
Autoclave / Sterilizer Qualification
Autoclave Validation / Qualification is mandatory for all machines used for biological sterilization, in the biomedical and pharmaceutical industries within the FDA, WHO & EU controlled areas. Sterilization can be accomplished by either physical or chemical means.
This benchtop autoclave validation sterilizer. As used for sterilization of instruments and porous loads in hospitals, private clinics and dental and veterinary offices.
The principal physical means is autoclaving; other physical methods include boiling and dry heat. Chemicals used for sterilization include the gases ethylene oxide and formaldehyde and liquids such as glutaraldehyde. Of all these sterilants, autoclaving is the fastest, most reliable and hence; most commonly used within the FDA, WHO and EU zones of influence.
It must always be remembered that it is also one of the easiest processes to get wrong. This is why regulators will nearly always scrutinize and ask about validation methods used in autoclave qualification / Qualification activities.
Autoclave validation / Qualification must follow the routine validation / Qualification document string of;
VP – URS – DQ – VRA – IQ – OQ – PQ
Cold Rooms, Warehouse and Room Mapping
Cold Chain Validation suddenly became a hot topic when the results of a government investigation into Cold Chain distribution compliance were published. The facts release indicated that nearly a quarter (23&precnt;) of all drugs distributed in the USA, are of unknown efficacy. The distribution of these temperature sensitive products in vehicle containers that lacked validated methods of maintaining the correct internal temperature or even the ability to produce a validated history of what the actual conditions were; has rendered these products ‘adultered’, i.e. of unknown efficacy or safety. Vehicle body internal temperatures; with seasonal variations, can range from a high of 50 to a low of -40 (degrees centigrade). In contrast the mandated internal temperature for distribution containers for standard drugs and medical products is 2 to 8 (degrees centigrade), with much lower temperatures specified for some drugs.
This shocking news has certainly guaranteed that Cold Chain Validation compliance will be top of everyone’s audit list, specifically when drug interactions with the end user are considered as critical. The implications of products being damaged and out of specification may induce many companies to replace doubtful goods or even trigger the regulators into initiating product recalls. This problem is expected to create a veritable stampede as distributors scramble to ensure that all the vehicles and containers they used in this essential everyday service, are rendered Cold Chain compliant, as soon as is possible.
Depyrogenation Ovens Qualification
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.
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)
- 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:
- AnimalsWater damaged books and documents