Founded in 2007, Aecan is India based firm providing consultation services to Medical Devices & related Industries.
Our Activities: -
1. To provide layout of plant in AutoCAD format as per Medical Devices Rules 2017, USFDA 21CFR 820 & CE guidelines to manufacture Medical Devices. The layout will include dimensions of each room & height as per machine height. It will include type of false ceiling (material of construction) / service floor to be provided, lighting & other electrical location in it. We will guide areas where GMP panels & where brick walls are to be used. Guide to select several types of GMP panels which are available e.g. PCGI Sheet panel (Powder Coated Galvanized Iron Sheet) or PPGI ( Pre Painted Galvanized Iron Panels). These panels can be PUF filled or Honey Comb filled as per your choice. Door size & opening direction will be decided as per usage. View panels, pass boxes will be provided on the walls as requirement. Type of flooring to be done viz. Kota Stone, Epoxy, PU Sheet etc.
2. To provide plumbing layout for Raw Water, Purified Water, Air Etc. GMP Drains, their size as per usage. ETP capacity to be installed, Raw Water Tank Capacity, RO & Purified Water plant & their storage tank make & capacity.
4. To provide in the layout electric points for machines, pass boxes, LAF, Fly killer, general lighting etc. To calculate total electric load of company, capacity of transformer, diesel generator, location of Electrical Panels. Selection of LED lights as per LUX level required.
5. To provide list of machine & instruments required, provide proper location for machines in layout, to provide source of machines with prices.
6. To approve all the drawings, quotation received from vendors.
7. To provide Design qualification & URS (User Requirement Specification) of Air Handling Unit along with details of class, pressure differential, temperature, air changes etc. required for production & laboratory.
8. To ensure that premises are constructed as per latest norms.
Liaison Work
1. To prepare all the documents required to be enclosed with licence application.
2. To submit application at Department.
3. To follow application & get inspection done.
4. To give reply to query raised.
5. Finally get Manufacturing Licence Granted.
GMP Documentation Work
1. To provide all the documents required for maintaining records as per Schedule MDR & ISO 13485 which consists of Standard Operating Procedure for all machines, SOP in Hindi, Master Formula Record, Process Validation, Cleaning Validation, Raw Material, Packing Material & Finished Goods Stock register, Log Books, Cleaning & Sanitization record, Training Record, Over Head Tank Cleaning Record, Under Test, Approved & Rejected Labels, In process Material Status Labels, Etc. & many more.
Aecan provides services for following types of plants.
Medical Devices Plant, Orthopedic Implant Plant, IV Cannula Plant Surgical Dressing Plant, Medical Oxygen Plant & Diagnostic Kits.
