Manufacturing Site Design and Conceptualization

The manufacturing site conceptualization and designing include the designing of the facility that meets the local and international cGMP requirements as expected by various regulators worldwide. The requirements include and not limited to the layout designing of manufacturing unit, achieving the regulatory expectations of the clean room, Adequate and compliant validation of the Equipment, instruments and utilities and related documentation.

Manufacturing Site Conceptualization Project Services Include Following Stages:

As medical device consultant we do the Manufacturing Plant Design Consulting Services For Medical devices like Orthopedic implants, surgical instrument, dental instrument manufacturing Industry, implant-manufacturing, implantable-moulding, diagnostic-instrument, Active medical devices like EGC machines etc, Disposable products e.g Syringes, IV cannula, IV set, DJ stents etc, Drug-device combination products like Prefilled syringes, Tropical products with applicator, Inhalers etc.

The services include but not limited to the following

Facility Layout & Design

The layout design of the facility is done as per the local and international regulatory expectations. Various aspects are taken under consideration while designing the layout like Storage requirements, Manpower requirements, Sterilisation requirements, Process requirements,  Local statutory requirements etc.

Regulatory Aspects of Clean Room

Depending on the product requirements, process requirements, Product sterilisation requirements, Product risk classification, We determine the parameters of the clean room as given ISO 14644 and regulatory expectations as per norms. We extend the said requirements to the Cleanroom suppliers for supplying the right systems to achieve the expectations.

Medical Device Process Validation

The Medical Device Process Validation, equipment validation and utility validation shall run through the adequate qualification/Validation life cycle that runs through major stages of the URS, FAT, SAT, DQ, IQ, OQ and PQ as applicable. The adequate validation master plan is prepared and executed. All the validation life cycle is documented through protocol and reports

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Keep In Mind!

The Manufacturing facility plays the major role in the licencing, certification, regulatory approvals and operating feasibility. Sometimes the compromised design of the facility may bring in irreversible damages on the regulatory approvals and the operational feasibility. During facility design, it is very important to know the current product to be manufactured and possible expected future product regime and their process flow.

Our Other Services

QMS & Certification
Regulatory Compliances
Medical Device/Drug-Device Combination Product Design & Development
Medical Device Post Marketing Support

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