Design Qualification of Medicament Preparation Vessel
- OBJECTIVE:
- To design, engineer and supply the Medicament Preparation Vessel and to provide assurance that the machine is manufactured and it complies with the Scope of Supply. To prove that each operation proceeds as per the design qualification and the tolerances prescribed there in the document, are the same at utmost transparency.
- SCOPE:
- The scope of this qualification document is limited to the Design Qualification of Medicament Preparation Vessel. This qualification document is part of a validation activity for the Medicament Preparation Vessel.
- RESPONSIBILITIES:
- CLIENT:
- To Check and Approve the design qualification.
- CLIENT:
- MANUFACTURER:
- To design, engineer and provide the complete technical details of the equipment pertaining to its design qualification viz.
- Machine overview
- General arrangement drawing
- Equipment orientation with layout
- Specifications of the sub-components/ bought out items, and their make, model & quantity, and backup records/ brochures,
- To design, engineer and provide the complete technical details of the equipment pertaining to its design qualification viz.
- Details of Utilities,
- Identification of components for calibration
- Material of construction of all components
- To confirm the safe delivery of the equipment to the user site.
- To ensure that no un-authorized and or unrecorded design modifications shall take place. If at any point in time, any change is desired in the mutually agreed design, Change control procedure shall be followed and documented.
- To ensure the proper installation and commissioning of the equipment.
- MACHINE DESCRIPTION:
- Medicament Preparation Vessel is used for mixing of ingredients and medicament. Medicament Preparation Vessel is comprised of following components.
- Shell
- Cylindrical, Vertical, AISI 316 L shell with top flat and bottom tapered flat end, having detachable cover on top. Surface finish is Mirror.
- Jacket
- Cylinder, vertical, AISI 304 jacket shell with bottom dished end and closure, stiffeners are provided on main shell.
- Insulation and Cladding
- 50 mm RBFG insulation with 1.6 mm thick AISI 304 welded cladding. The outside surface finish is Matt.
- Support
- 04 Nos. of leg support with SS castor wheel are provided.
- TECHNICAL SPECIFICATIONS OF COMPONENTS & SUB -COMPONENTS USED / BOUGHT OUTS
| Description | Specification |
| 1. Equipment Description | |
| Name | Medicament Preparation Vessel |
| Surface Finish | mirror (Internal)
Matt (external) |
| Overall Dimension | 780 mm (D) X 1150 mm(H) |
| Nozzle | 05 Nos.
N1 : Outlet Connection N2 : Jacket Connection N3 : Jacket Connection N4 : Jacket Vent Connection N5: Dial type Temp. Gauge Connection |
| Insulation | RBFG type, 50 mm (T), 2 mm (T) SS 304 cladding |
| Support | AISI 304 legs (04 Nos.) with SS castor wheel |
| Capacity | Working :- 150 L
Gross :- 170 L |
| MOC | Contact :- AISI 316 L
Non – Contact :- AISI 304 Gasket:- Silicon |
| Design Condition | Shell: -1 to Atm.Bar g@1200C
Jacket :- 2.5 Bar g@1200C |
| 2. Flush Ball Valve for Product Outlet | |
| Type | Manual Ball Valve |
| Make | Seeco |
| Size | 1 ½ ” |
| Mounting | Pad Welded |
| MOC | AISI 316 L |
| 3. Vent Valve for Jacket | |
| Type | Manual Ball Valve |
| Make | Seeco |
| Mounting | 3/8” BSP |
| MOC | AISI 304 |
| 4. Castor Wheel | |
| MOC | SS castor with PU coated nylon wheel |
| Qty. | 04 Nos.
Swivel: 02 Nos. Brake : 02 Nos. |
- DETAILS OF UTILITIES
| Description | Specified |
| Hot Water | To be provided |
| Chilled water | To be provided |
- ENCLOSURES
| Sr. No. | Description | Drawing No. |
| 1 | General arrangement drawing of Medicament Preparation Vessel |
- MOC OF CONTACT PARTS:
| Description | Specification |
| Main Shell, 4 mm | AISI 316 L |
| Top Cover, 1.6 mm | AISI 316 L |
| Body Flange, 20 mm | AISI 316 L |
| Bottom Dish, 4 mm | AISI 316 L |
| Jacket Shell, 3 mm | AISI 304 |
| Jacket Dish, 3 mm | AISI 304 |
| Jacket Closer, 5 mm | AISI 304 |
| Jacket Stiffener, 3 mm | AISI 304 |
| Insulation Shell, 1.6 mm | AISI 304 |
| Pipe for Leg, 2” NB x Sch.10 | AISI 304 |
| Pipe for N2, 3, 1” NB x Sch.40 | AISI 304 |
| Plate flange for N2 & N3, 16 mm | AISI 304 |
| Tube for N4, 5/8” O.D. x 16 SWG | AISI 304 |
| Rod for N4, 35 mm | AISI 304 |
| Rod for N5, 35 mm | AISI 304 |
| ‘O’ Ring | Food Grade Transparent Silicon Rubber |
- CHANGE CONTROL PROCEDURE:
- Change in the agreed design shall be addressed through the well-defined Change control procedure.
- DESIGN QUALIFICATION REPORT.
- LIST OF ABBREVIATIONS
| cGMP | current Good Manufacturing Practices |
| GEP | Good Engineering practices |
| MS | Mild steel |
| NFLP | Non Flame Proof |
| SS | Stainless Steel |
| KW | Kilo Watt |
| DQ | Design Qualification |
| FAT | Factory acceptance test |
| VFD | Variable frequency drive |
| RPM | Revolution per minute |
| MMI | Man machine interface |
| SCADA | Supervisory control and data acquisition |
| MCB | Miniature circuit breaker |
| VFD | Variable Frequency Drive |
| MOC | Material of Construction |
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