Ishanvi Technical Services LLP - THERMAL VALIDATION

THERMAL VALIDATION

Ishanvi Technical Services LLP is a leading specialist provider of validation services.

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 specialize 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.

BOD Incubators/ Deep Freezers / Walk In Freezers/ Refrigerator

A freezer is a storage unit used in pharmaceutical industry to store contents such as samples and other medical material just below the freezing temperature. There are basically two styles of freestanding freezers - chest and upright models. Freezers have a long lifespan with most models having an expected lifecycle of twenty years for chest models and shorter for uprights, especially self-defrost models. There are also walk-in style freezers for bulk storage.

Sterilizer Validation

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.

SIP System

A Sterilization In Place (SIP) installation will usually comprise one or more pieces of processing equipment, such as a fermentor and a centrifugal separator to handle harvests, connected by rigid stainless steel or flexible Teflon -lined piping. The installation will be capable of withstanding steam pressure up to, say, 20 psi and corresponding sterilizing temperatures in the 121° to 125°C range. There will be a supply of steam suitable for the procedure, under pressure control and a "trapped" drain at a low point on the system, which will pass condensed water, but not steam. The safe operation of the installation will be controlled by suitable safety valves or "burst disks".

CIP System

Validation of cleaning procedures has generated considerable discussion since agency documents, including the Inspection Guide for Bulk Pharmaceutical Chemicals and the Biotechnology Inspection Guide, have briefly addressed this issue. These Agency documents clearly establish the expectation that cleaning procedures (processes) be validated.

Dry Heat Ovens

Components and products. Dry heat sterilization is often used for heat-stable oils, ointments and powders. Most often, dehydrogenation of parenteral containers is performed utilizing a dry heat oven. The dehydrogenation 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 dehydrogenated components, on a reproducible basis.

The validation of a dry heat sterilization and dehydrogenation 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.