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For a pharmaceutical company, the manufacturing facilities are at the core of its ability to provide quality products that meet regulatory requirements. At Inven, we have 3 manufacturing units, all complying with cGMP specifications to help us meet national as well as global demand for superior quality LVP products
Inven's manufacturing areas are designed to comply with cGMP guidelines so as to maintain class conditions, prevent cross-contamination and avoid mix-ups. Man and material flow is designed to be linear and easy to follow. At Inven, it is our constant endeavor to demonstrate an on-going compliance with cGMP. Filling and sealing processes are performed in Class 100 conditions that are achieved through the validated use of Laminar Air Flow units fitted with HEPA filters. The other manufacturing areas conform to Class 10,000 conditions; all areas are monitored through regular testing to ensure the class conditions are maintained as specified by cGMP guidelines.
At Inven, we have designed and developed a unique form-fill-seal procedure FIO®. This moulds polypropylene polymer containers, fills them aseptically and performs hermetic sealing of the containers as part of a single, sequential operation. The FIO®aseptic machine is equipped with an integrated clean room modular design; the machine works on a fully automatic basis and uses a time-pressure-dosing system to ensure accurate fill.
However, it is not enough to merely develop an advanced technology; one ought to ensure it works optimally when it is used in the correct manner. Therefore, we provide our personnel involved in the different stages of LVP manufacture with regular and relevant training to help them appreciate the finer points of this new technology as well as the criticality of abiding by cGMP guidelines.
A facility is as good as the quality of the utilities with which it is supplied. At Inven, we take utmost care to ensure that our utilities comply with cGMP guidelines. The HVAC environment is maintained as per the specifications of Schedule M of the Drugs and Cosmetics Act of India. The core filling area is periodically monitored for consistency in class conditions in keeping with a predetermined testing protocol. The Quality Assurance department plans and executes regular programs for validation of the HVAC and water systems; all equipment involved in the utility and manufacturing areas are calibrated and validated as per our in-house protocols.
