Cleanroom & HVAC Validation

  Home   |   Cleanroom & HVAC Validation
cleanroom-and-hvac-validation

HVAC and Cleanroom Validation

  • HVAC - Stands for Heating; Ventilating & Air Conditioning It includes a variety of active mechanical/electrical systems employed to provide thermal control in buildings.
  • H - Heating system adds thermal energy to a space or building in order to maintain some selected air temperature that would otherwise not be achieved due to heat loss to the exterior environment.
  • V - Ventilating system is intended to introduce air to or remove air from a space to move air without changing its temperature. Ventilating systems may be used to improve indoor air quality or to improve thermal comfort.
  • AC - Air Conditioning system removes thermal energy from a space or building to maintain some selected air temperature that would otherwise not be achieved due to heat gain from interior heat sources and the exterior environment.

As per ASHRAE (American Society of Heating, Refrigerating & Air conditioning Engineers), HVAC system should fulfil four objectives:

  • Control air temperature
  • Control air humidity
  • Control air circulation
  • Control air quality

Validation What Is It?

Validation

Documented series of actions that prove that any procedure, process, equipment, material, activity or system perform its intended functions adequately and consistently and lead to expected result of uniform batches that meets the required specifications and quality attributes.

Importance of Validation

Validation studies are an essential part of c GMP and should be conducted in accordance with predetermined protocols. As written report summarizing recorded results and conclusion should be prepared and stored, Process and procedures should be established on the basis of validation study. Validation often requires joint efforts — planning & expertise from several groups, of departments that helps to perform the validation exercise and documentation includes formulation development, Engineering, production, Quality assurance & quality control.

validation

Re- Validation

It involves the repeat of initial process validation to provide assurance that changes in the process and/ or in the process environment, whether intentional or unintentional, do not adversely affect the process characteristics and product quality.

Since the plans will be in place the day the deal closes, the merged company can immediately begin implementing the synergy projects needed to realize the value it is seeking.

The validation master plan is a written plan stating how validation will be conducted, including test, Parameters, product characteristics, production equipment and decision points on what constitutes acceptable test results.

Validation required by law to confirm to CGMP regulations. Good business dictate that manufacturers avoid the possibility of rejected or recalled batches. Validation helps to ensure product uniformity, reproducibility & consistency in quality. Validation helps to reduce the extensive in process sampling during regular production. The pharmaceutical industry is a subject to cGMP requirement, with testing and validation of cleanroom is the most critical parameters.

Our major stress has always towards the Quality and to follow up the work as per c GMP, ISO and other pharmaceutical guidelines. Regular validation minimize the product defect , costly downtime and hence increase the productivity, as we are providing the independent customer —friendly clean room validation service with our sophisticated well calibrated instrument. Quality service is very important factor in clean room validation work, and we use latest advanced instrument, calibrate as per frequency and having the trained technical staff for validation work. Company having our own SOP, s to carry out the validation work and all staff which are performing the activity on site are aware with SOPs, ISO guidelines for testing methods, c GMP, EU, USFDA guidelines.

Why Validation

Validation required by law to confirm to cGMP regulations. Good business dictate that manufacturers avoid the possibility of rejected or recalled batches. Validation helps to ensure product uniformity, reproducibility & consistency in quality. Validation helps to reduce the extensive in process sampling during regular production. The pharmaceutical industry is a subject to cGMP requirement with testing and validation of cleanroom is the most critical parameters.

Our major stress has always towards the quality and to follow up the work as per cGMP, ISO and other pharmaceutical guidelines. Regular validation minimize the product defect, costly downtime and hence increase the productivity, as we are providing the independent customer-friendly clean room validation service with our sophisticated well calibrated instrument. Quality service is very important factor in clean room validation work, and we use latest advanced instrument, calibrate as per frequency and having the trained technical staff for validation work. Company having our own SOPs to carry out the validation work and all staff which are performing the activity on site are aware with SOPS, ISO guidelines for testing methods, cGMP, EU, USFDA guidelines.



Cleanroom Validation

What Is A Cleanroom?

A cleanroom is a controlled environment where pollutants like dust, airborne microbes, and aerosol particles are filtered out in order to provide the cleanest area possible.

How Does It Work?

Essentially, cleanrooms work to remove pollutants, particles, and contaminants from outside ambient air, Outside air is first circulated to a filter system. The filters (either HEPA or ULPA) then clean and decontaminate this outside air according to their specifications. The filtered air is then forced into the cleanroom Additionally, contaminated air within the cleanroom is forced outside the room by registers, or it is recirculated back into the filters, and the process restarts.

Who Needs A Cleanroom?

There are a wide variety of reasons that a company may need a cleanroom. If you're manufacturing something that is easily affected by contaminants or particles in the air for example, it's likely that you'll need a cleanroom. Here are some common industries that regularly use cleanrooms.

  • Manufacturing companies
  • Medical laboratories
  • Electronic part production
  • Research facilities
  • Aerospace industry
  • Nanotechnology production
  • Pharmaceutical companies
  • Optics and lens manufacturing
  • Military applications
What is Cleanroom Validation and Why Is It Important?

In addition to acquiring the necessary equipment when building a cleanroom, the environment must comply with clean air safety regulations in order to operate efficiently, both in process and cost.

Cleanroom validation involves conducting a series of tests to determine whether these guidelines are being met, such as ISO 14644:2015 and guidelines from the Medicines and Healthcare Products Regulatory Agency (MHRA).

Cleanroom validation is important as it also aids in the detection of harmful contamination sources, ensuring peace of mind that your critical processes remain protected. Failure to comply with validation standards puts your business at risk of high maintenance costs and disrupted operations, the frequency of which should be defined by your business' individual risk assessment.

Our Services

Service Offering

Israel

Saudi Arabia

UAE

Nigeria

Ireland

Bangladesh

Vietnam