Operon Strategist is a leading regulatory & quality assurance consultant for medical device & primary packaging manufacturers. Working out of Pune, India, Operon Strategist has a global presence with an international client base We are Provide Medical Device Turnkey Project Consulting Services In USA, Dubai, South Africa, New York, Qatar, Algeria, Libya, Shri Lanka, Australia, Mauritius, Costa Rica.
Medical device manufacturers looking to set up new manufacturing unit can avail our turnkey project services. As medical device project consultants , we provide a complete package of turnkey services including layout design,clean room Design , validation, developing quality system, documentation, training & implementation services In Pune , Delhi , Gujrat , Bangalore , Ahmedabad , Hyderabad , Chennai , Noida , Mumbai , India , Rajkot , Vishakhapatnam , Andhra Pradesh ,Chandigarh , Kolkata, Madhya Pradesh , Valsad ,Vizag.
Clients can avail the complete package of turnkey project services or it can be customized to meet the immediate requirements of the client. We as clean room design consultant, guide Medical Device manufacturers on supporting elements to maintain the clean room conditions suitable for manufacturing like Entry-exit procedures, Gowning procedures etc.
The services that we provide as medical device turnkey consultant include Facility layout & design Facility layout & design is an important element for setting up a new manufacturing facility. Appropriate regulatory and cGMP requirements have to be considered while designing the layout and required approvals must be taken from the local regulatory authorities. Layout designing helps to determine the space requirements for various processes and their associated equipment/machinery. We incorporate design in such a way to ensure unidirectional flow of man and material and prevent cross-contamination. We also consult manufacturers on plans for future expansion or change & accordingly design the facility layout. We incorporate efficient space utilization for maximum layout effectiveness in our designs.
Clean Room Design Consultant Many medical devices are manufactured & supplied sterile. In order to facilitate sterilization of devices, it is recommended to maintain low levels of bio-burden so that sterilization can be effectively carried out. Higher levels of bio-burden results in use of higher concentrations of gas or radiation or require longer durations of exposure which may drastically affect the product. Depending on the level of air quality desired, different classes of clean rooms are constructed ranging from Class 1 to Class 100,000 as per the US FED STD 209E clean room standards. Medical devices may be sold unsterile and sterilized at user’s end. It is recommended to manufacture such devices with low levels of bio-burden which is achieved by performing manufacturing activities under clean room conditions. Clean room helps in establishing and maintaining low levels of dust, airborne microbes, aerosol particles and chemical vapors by building the desired class of clean room. Operon Strategist in consultation with the client determines the bio-burden & sterility requirements for the medical device. Accordingly, the clean room classification for each room is determined. The classified areas are also reflected in the factory layout design to give a better clarity to the client about classified & unclassified areas. Operon Strategist as clean room design consultants coordinates with clean room providers to convey the exact requirements to prevent any miscalculations while designing the clean room.
Medical Devices Validation services Validation is an important cGMP requirement & many regulatory agencies audit the validation documentation. Validation of a machine or a process is carried out to ensure that products of consistent quality are manufactured and required level of compliance is met at every stage. Since a wide variety of procedures, processes & activities need to be validated; validation is divided into the following sub-sections: • HVAC validation • Equipment validation • Process validation • Facilities validation • Cleaning validation • Analytical method validation • Personnel validation • Packaging validation •Computer system validation Being a medical device consultant, Operon Strategist guides manufacturers & validation service providers for the validation activity & documentation. The product and the production facility are studied to document the validation master plan according to which validation activities will be performed as per the defined timeline.