| Turnkey Services |
|
Detailed Engineering Services
|
|
| 1. Civil |
|
| 2. Electrical |
|
| 3. Lighting |
|
| 4. Air Conditioning and Ventilation |
|
| 5. Utilities |
|
| 6. Drainage |
|
| 7. Aids and Accessories |
|
| 8. Process |
|
| 9. Equipment |
|
| 10. Drawings |
|
| 11. Equipment |
|
|
|
|
1. Civil :
|
|
|
|
Prepare Area Statements |
|
|
Design an optimal layout within the area available confirming to CGMP requirements. |
|
|
Lay down flooring specifications with slopes |
|
|
Specify suitable wall thickness and prepare elevations showing glazings, doors, risers, pipelines and power points. |
|
|
Specify suitable sections for glazings and give detailed designs for the same. |
|
|
Specify door designs at various locations. |
|
|
Specify the height of slabs. |
|
|
Specify cutouts in slabs for * Utilities * Lighting * Filters * Drainage * Air-ducts |
|
|
Give coving details for sterile area. |
|
|
Give tentative Bar charts for civil works. |
|
|
Check and approve sample floorings. |
|
Guide the civil contractor at various stages, for CGMP aspects of construction. |
|
|
|
| |
|
| 2. Electrical: |
|
|
|
Prepare a list of connected load. |
|
|
Design electrical distribution systems. |
|
|
Lay down flooring specifications with slopes |
|
|
Design specifications for main control panel and distribution panels. |
|
|
Design electrical line diagrams showing cable lengths and sizes. |
|
|
Design power socket schedule and location points. |
|
|
Design earthing circuit diagrams. |
|
|
Prepare bill of material. |
|
|
Guide electrical contractors at various stages. |
|
|
|
|
|
| 3. Lighting : |
|
|
|
Design illumination levels in various rooms and suggest suitable fittings. |
|
|
Design specification for distribution boards. |
|
|
Design emergency light systems. |
|
|
Design wiring routes and suggest circuit controls. |
|
|
Prepare list of connected load. |
|
|
Design insectocutor systems. |
|
|
Guide the contractors during various stages. |
|
|
|
|
|
| 4. Air Conditioning and Ventilation: |
|
|
|
Specify environmental conditions for different areas. |
|
|
Specify A.C. tonnage/capacities/static heads for various AHU/FCU to achieve desired environmental conditions. |
|
|
Design necessary ductings, duct ratings, AHU/FCU locations. |
|
|
Detail the ducts showing dampers, fire dampers, rexin connectors and manometer locations. |
|
|
Prepare insulation specifications. |
|
|
Prepare chilled water piping and condensed water piping details. |
|
|
Suggest suitable air curtain locations and capacities. |
|
|
Prepare schedules in co-ordination with your contractor with respect to associated activities. |
|
|
Prepare bill of materials for major items. |
|
|
Guide the contractor during various stages of installation. |
|
|
Assist in carrying out validation as per specifications. |
|
|
Invite quotations from suppliers for filtration systems. |
|
|
Carry out a comparative analysis of the quotations in terms of conformity to specifications and other commercial aspects. |
|
|
Submit recommendations for selection of suppliers on the basis of above analysis. |
|
|
Assist clients, if required, in finalising orders. |
|
|
Follow up with suppliers for timely delivery. |
|
|
To assist in necessary validation of filters by DOP / Particulate count / Fungal count / Bacterial count test. |
|
|
|
|
|
| 5. Utilities: |
|
| |
Design requirements for the following requisite utilities:· Raw water · D.M. Water · Distilled water· Steam · Compressed air· Nitrogen· Vacuum · Oxygen · LPG· Steam condensate return |
| |
Design and specify suitable routes with drawings and mounting details for the piping system for above utilities. |
| |
Specify MOC for various piping. |
| |
Specify suitable fittings. |
| |
Specify locations of utility equipment's. |
| |
Prepare elevations of various pipelines. |
| |
Submit bill of materials for all major items |
| |
Guide the contractors during various stages of implementation. |
| |
Prepare bar-charts. |
|
|
|
|
|
| 6. Drainage: |
|
|
Prepare drainage requirements for various areas. |
|
Prepare schedule of drain pipes for various locations. |
|
Specify MOC for drain pipes. |
|
Prepare schedule for inspection chambers in the line. |
|
|
|
|
|
| 7. Aids and Accessories : |
|
|
Specify list of aids and accessories like chairs / tables / material handling equipments, ladders, scoops, telephone locations and fire extinguisher types and locations. |
|
|
|
|
|
| 8. Process: |
|
|
Calculate optimal batch size on product mix basis. |
|
Prepare suitable flow charts confirming to process requirements. |
|
|
|
|
|
| 9. Equipment: |
|
|
Suggest suitable machines and toolings for the given product mix and fill sizes confirming to desired specifications. |
|
Prepare detailed specifications of various machines and tooling. |
|
Prepare detailed specifications for packaging inputs like Vials/Ampoules/Stoppers and Seals. |
|
|
|
|
|
| 10. Drawings: |
|
|
The following drawings will be submitted : |
|
|
Building
• Site layout details.
• Area layout.
• Wall Elevation.
• Flooring details.
• Door schedules.
• Machine layouts.
• Glazing details.
• Typical Glazing Sections.
• Drainage details.
|
|
Air Conditioning/Ventilation
• Sectional detail of A/C systems.
• Sectional detail of Ventilation systems.
• Ducting layout.
• Grill layout. |
|
Power
• Single line layout.
• Lighting and Grill layout.
• Lighting layout of service slab.
• Control point layout.
• Distribution boards layout.
• Power socket layout.
• Cable route.
• Specification sheets.
• Insectocutor locations.
• Air Curtain locations
• Emergency light locations
|
|
Utility/Process Pipelines :( Raw Water, D.M. Water, Chilled Water, Steam,Compressed Air, Nitrogen, Oxygen, LPG and Vacuum ).*
• Schematic diagrams.
• Point locations.
• Flow diagrams.
• Combined Pipeline Layout Isometric.
• Physical diagram of pipelines.
• Multi Cylinder Gas Manifold System. |
|
|
|
|
|
| Machinery Procurement And Inspection Services |
|
| 11. Equipment : |
|
|
Prepare a time schedule for completion of Project in terms of bar-charts for supply of machines. |
|
Co-ordinate with manufacturers for
• Timely deliveries
• Followup, as and when necessary
• Stagewise inspection for critical equipments
• Final inspection and trials at suppliers premises alongwith your
• Representative if desired
|
|
Prepare inspection reports. |
|
Co-ordinate with suppliers for installation and commissioning of the machine and ensure line integration. |
|
Arrange for proper documentation from respective suppliers of critical equipment. |
|
Lay down validation criteria for all major/critical machines. |
|
Assist you/supplier in carrying out validation. |
|
|
|
