Autocal Solution Pvt. Ltd

Vasai, Mumbai, Maharashtra

We provide and extensive range of services pertaining to clean room validation by our panel of expert professionals available with us.

Computerized Systems (CS) using Programmable Logic Controllers (PLC) have been utilized for controlling drug manufacturing equipment (hereafter, manufacturing equipment). Such a CS is referred to as a PLC-Based CS (PBCS). Upon the use of PBCS, the regulatory authorities require drug manufacturers to prove that their CS has adequate functions and performance. Along with the sophistication of manufacturing equipment functions, the PBCS functions have also become complicated. This has made it difficult to prove the adequacy of the functions and performance.

Cleanroom ValidationHVAC Validation is performed for a variety of reasons. To ensure that the design of the facility is fit for its intended purpose; to ensure that the facility, equipment, and environment meets User Requirement Specifications (URS); to ensure that the facility, equipment, and environment meet defined regulatory requirements; to ensure that the facility, equipment, and its environment function together as a system to meet defined standards.