Objective for URS of Static Pass Box :
This document is generating for the purpose of specifying the URS of Static Pass Box. The URS of Static Pass Box is provided to define the important components, variables and options necessary for the Supplier to provide a functional of dynamic pass box that meets the needs in the most cost-effective method possible. The URS is also provided to the Supplier to provide a price quote for the supply for multi-mill machine including the design, Performance and manufacture of the equipment.
The Static pass box will be interfaced to the output and will be located in a designated operating area and a cGMP operation.
Table of Content for URS of Static Pass Box
| Description |
| Title page |
| Table of contents |
| Approval of Documents |
| Objective |
| Scope |
| Location of equipment |
| Communication |
| Applicable codes and standard |
| System/equipment/instruments details |
| Scope of supply |
| Brief system description |
| Technical specification |
| Safety features |
| List of Abbreviations |
Approval of Documents:
Prepared by:-
| Name | Designation/Department | Signature | Date |
| Executive/ QA |
Reviewed by:-
| Name | Designation/Department | Signature | Date |
| Manager/Production | |||
| Manager/Engineering |
Approved by:-
| Name | Designation/Department | Signature | Date |
| Manager/QA |
Scope:
- The scope of this document is to define the requirements of the static pas box in pharma company.
Location of equipment:
- Static pass box will be installed in the new hormone area with Class D/ CNC background.
References
- Reference has been taken from the existing equipment and from the internet or vendor brochure
System/equipment/Instruments details URS of Static Pass Box:
| Name of the equipment | Static pass box |
| Model/Type | As per cGMP model |
| Pass box type | 3 way opening / 2 way opening (As per requirement) |
Scope of Supply:
| Type of Device | Static pass box |
| Machine Standard | The current state of the art GMP Compliance. European medicine agency (EMA) and WHO, Regulations compliance. |
| Machine design standard for safety | The European machinery Directive 2006/42/EC.ISO 13852:1996 safety of machinery -safety distance to prevent danger zones being reached by upper limbs.ISO 13853:1996 safety of machinery safety distance to prevent danger zones being reached by lower limbsISO 13854:1996 safety of machinery- minimum gaps to avoid crushing of parts of the human body.ISO 14110:1998 safety of machinery- interlocking device associated with guards- principles for design & selection. |
| Room Condition | Room Temperature: – NMT 25 degree Celsius.Relative humidity: – NMT 55 %Zoning: Class D Grade /CNC Pressure:15/ 10 Pa |
| Features | Design conforming to cGMP standardsSS 316 & SS 304. Easy cleaning designed with easy removal weight adjustment sector. |
| Document & Certificate | Manuals and Maintenance Instructions Operator manualInstallation and assembly instructions for all devices.User’s manuals for all components.Trouble shooting guide.Maintenance Manual.Safety instruction.Training documentation. Electrical and Control diagrams Single line drawing for electrical distribution.Circuit diagramsCable list.Equipment location drawing for electrical equipment and instruments. |
| Qualification Protocols | DQ Protocols and reports.IQ protocol and reportOQ Protocol and reportVendor should organize for Execution of IQ/OQ and support for PQ |
| Training | Vendor should impart necessary Operational training to user department and maintenance training to maintenance department. |
| Test ,Calibration, MOC Certification | All test certificate for brought items will be provides MOC Certificate will be provided |
Brief system description:
- Static pass boxes are used to transfer materials between two rooms of equal cleanliness levels and are designed for minimal personnel movement the interlock is in mechanical form. When one door is opened, the other door cannot be opened. One door must be closed before the other door can be opened. The electronic interlock use integrated circuits, electromagnetic locks, control panels, and indicator light.
- The Static Pass Box is designed as an air-lock device to prevent ambient air from entering or clean air from disappearing from the clean room.
- When the material is put inside pass box & the door is closed, UV light will turn on and material is placed under UV for some time to kill bacteria. Then the material can be taken out
- The basic construction of the machine consists of :
- Standard stainless steel 316 for contact parts
- Non contact parts SS304 with matt finish
- Non metallic contact parts, any material with food grade quality having no potential impact on the products
Body:
The body of the box consists of the outer casing and the inner chamber.
Doors:
Two doors (one on each side) with tempered glass windows sealed by durable feather edge rubber prevent airborne particles contamination. Besides, each door has door handle. The door handles are different according to the types of interlock system
Interlock system:
This is an important of every pass box, ensuring two doors don’t open at the same time. this prevent the risk of cross contamination in clean rooms
UV Light
UV light are designed inside pass box for disinfection of transferred objects before entering the clean room
Electrical chamber and mechanical chamber:
All mechanical components such as gears, motors, and moving belts, as well as electrical components such as wiring, switches, and MCBs, are installed in this segment.
Technical Specification for URS of Static Pass Box:
| Machine weight | As per requirement |
| Model/Type | As per cGMP model |
| Overall dimension (mm) | As per requirement |
| Working dimension (mm) | As per requirement |
| Pass box type | 3 way opening / 2 way opening (As per requirement) |
| General components | Main cabinet Door release button Electromagnetic interlocking Power supply plug On/off Switch LED Tube light UV Light Hour meter Switch Socket Light indicators |
| Doors | 3/2 side Door with Glass Window – SS Handles and SS Hinges |
| Interlock | Electronic interlock system |
| Alarm system | Preferably the sound alarm/beep shall be provided along with light indication |
| Power failure /recovery | In the event of power failure the system shall protect product against damage. The system will stop in a safe mode automatically upon loose of electricity, air & other major utility and will require operator intervention to restart. |
| Identification | Details of Make, Name, Serial. No., Capacity, Model and Year of manufacture should be available |
| Utility Requirement | 230 V ac, 1 Ph. 50/60Hz. |
Safety Features:
| Critical Variables | Acceptance Criteria | Reference |
| MCB | MCB is provided so that when there is an overload in current or any short circuit then the MCB trips. | Safety Requirement |
| Mechanical Guard | Mechanical guard for all rotating parts. | Safety Requirement |
| Joints | Welding of joints without any welding burrs. | Safety Requirement |
| Metal Parts | All the metal parts should be properly grounded without any sharp Edges. | Safety Requirement |
| Leveling and Balancing | Equipment should be properly balanced & leveled. | Safety Requirement |
| Installation | All the Installation must be in accordance with the cGMP. | Safety Requirement |
| Electrical Wiring And Earthing | Electrical wiring should be as per approved drawings. Double external Earthing to control machine (panel and motors) and operator should be provided. | Safety Requirement |
| Emergency/Safety Switch | Provided easy access position | Safety Requirement |