We at Pharmaline Group Inc understand the stringent compliance requirement of Cleanroom Industries.
Design-build creates efficiencies in the design phase, minimizing on-site labor. Pharmaline Group Inc combines its expertise with top engineering team to offer the advantages of design-build to our clients and satisfy their needs for world-class facilities.
The core component of any such facility is HVAC System which has to be designed and delivered considering various international standard.
We at Pharmaline Group Inc analyse your requirements and design and select theright system for your facility.
A specialized technical team will accompany you throughout the process.
Pharmaline Group Inc technical team is made up of engineers who are specialised in HVAC products and with extensive experience in the sector. They will develop your project as per Standard requirement or deliver the project as per consultant design, advising you throughout the entire process. All our installations are backed by an exhaustive study conducted by this team.
The necessary training for operation and maintenance of the system is provided by our expert technicians at the system start-up and commissioning, ensuring a full understanding of how the equipment works. Different training for different access levels to the system is taken into account and recorded and documented. Action options and limitations for the End-User, which are diversified according to the access level, are clearly highlighted during training.
The standards of good manufacturing practice (cGMP) require special attention to risk assessment and verification procedures: “it is requirement of good manufacturing identify the activities of validation necessary to demonstrate control critical aspects of particular operations. The significant changes made to installations, equipment and processes, which may affect product quality, should be validated. A procedure for risk assessment should be used to determine the scope and extent of validation.”
The Validation Master Plan serves to make sure that all equipment, procedures, that may affect the quality or integrity or effectiveness of the product, are validated; it contains the general principles which comply during the validation task, and plans activities to be carried out for this purpose
Environments controlled in accordance with Pharmaline Group Inc and FDA standards
We work in compliance with the regulations of the European Good Manufacturing Practices (Pharmaline Group Inc) and the Food and Drug Administration Agency (FDA), of the US Department of Health
ASHRAE (The American Society of Heating, Refrigerating and Air-Conditioning Engineers)
SMACNA (Sheet Metal and Air Conditioning Contractors’ National Association)
NFPA (National Fire Protection Association)
IECC (International Energy Conservation Code)
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