Hospaccx has large network of expert and global and local suppliers. We take a complete responsibility to undertake complex and unique projects and deliver quality and timely solutions which meet industry safety standards. We as a team offer project execution in accordance with the specific requirement of Procedure Specific Devices by our clients. We provide turnkey solutions also from green field to commissioning of facility as per international regulatory norms.
We always aim to provide complete assistance to your projects which include service as follows:
- Manufacturing plant layout design: It is the basic step for manufacturing plant setup. Medical Device Manufacturing should be compliant with rules given by respective regulatory bodies like USFDA, CDSCO etc. Man, and Material are the primary considerations for right design of the facility. The segregation of Procedure Specific Devices, its manufacturing and process flow and the use of classified area plays an important role. We have a team of experienced professionals which ensures correct decision making and smooth transitions during the audits from regulatory bodies and customers. The manufacturing layout is prepared by experts based on inputs from clients and their architects.
- Consultation for Future Expansion: We incorporate design of your manufacturing unit in such a way that it ensures unidirectional flow of man and material. We at Hospaccx, help you in consultation for your future plans as well which accordingly change the manufacturing layout.
- Primary packaging Layout Design: It is an important element while setting a manufacturing Unit for Procedure Specific Devices. Our consultants while designing the facility give prime consideration to the Regulatory Requirement, In particular, The Cgmp requirement. The layout thus designed to ensure a smooth flow of man and material through the plant.
- Clean room Conceptualization for Primary Packaging: We help our client conceptualize the design of clean room in the manufacturing facility as it maintains low level of Environmental pollutants such as dust, Airborne microbes, Aerosol particles and Chemical vapors.
- Primary packaging process Validation: We at Hospaccx, guides manufacturers and validation service providers on the validation activity and documentation. Our team of expert study the Procedure Specific Devices, their production facility and accordingly design the master plan which outlines the packaging process validation activities to be performed and timeline for the same.
Therefore, Hospaccx provide a complete solution to your Turnkey Design project for Procedure Specific Devices by providing consultancy worldwide including strategic, regulatory and environmental compliance. Our team of expertise helps our client in establishing highly regulated industry to achieve compliance, efficiency and sustainable business success.
