User Requirement Specifications

Transcription

1 Page 1 of 18 User Requirement Specifications Fluid bed drier Equipment ID: T-FBD01

2 Page 2 of 18 Table of Contents 1.0 APPROVAL SIGNATURES 2.0 OVERVIEW 3.0 PROCESS DESCRIPTION 4.0 PRODUCTIVITY REQUIREMENT 5.0 SAFETY REQUIREMENT 6.0 GMP REQUIREMENTS 7.0 TECHNICAL REQUIREMENT 8.0 GOOD ENGINEERING PRACTICES REQUIREMENTS 9.0 CONSTRAINTS

3 Page 3 of Approval signatures This document is prepared in line with GMP requirement. project management of GAPL and same shall be approved by following official of GAPL. Prepared by Name/ Designation Signature Date Mr. Pundalik N. Dhond, Jr. Officer Production Checked by Name/ Designation Signature Date Mr. B. Demello, Maint. Engineer Approved by Name/ Designation Signature Date Mr. Govind R. Tilve, Manager Production/ESU Authorized by Name/ Designation Signature Date Mr. D.N. Shetty, DGM QC/QA

4 Page 4 of Overview 2.1 Project Standard The facilities, upon completion, shall be in compliance with the cgmp requirement of Drugs And Cosmetic Act-1940/ WHO and also the GAPL s internal quality standards. 2.2 Equipment description The fluid bed drier will be used for drying of granulated mass/ granules/ excipients used for the production of tablets. The equipment provides- Mixing: The inherent turbulence in the fluidized bed provides fast, efficient mixing and drying. Drying: A fluidized bed is formed when an upward flow of process airlifts small solid particles/granules. As a result, the small particles/granules move rapidly within the fluidized bed and ensure a very efficient heat and material exchange between the bed and the fluidizing air. The temperature in the fluidized bed should be constant across the whole height of the bed to ensure gentle and uniform drying.the fluid bed drier shall consist of the following:- a) Inlet Air Handling Unit b) Machine Tower with inlet Air Plenum, Product container, Expansion chamber and a Filter housing. c) Exhaust Air Fan. d) Controls panel - : Control system is to control critical process parameter and to generate alarms. Area of installation.l X B X H i.e.7.5x2.5x3.75 mtrs 2.3 Reference standards/guidelines for equipment The equipment should comply with the following guidelines / standard: GMP-Regulations Current Good Manufacturing Practice for finished Pharmaceutical products. Note: 1) This URS has been prepared based on our in-house kwledge & understanding for this equipment. It is possible that certain points might have been overlooked. As a vendor we expect you to go throughthe document in depth and give your suggestions separately as an option. However, the base offer shall be as per the URS. All suggestions and deviations shall be highlighted and summarized separately. 2) Vendor shall provide response as or No against each specification for the compliance of their offered equipment in the remarks column.

5 Page 5 of 18 Specifications Remarks 3.0 Process Description 3.1 Input &Charging method Semidried powder/ dry powder from the PLM shall be transferred into the FBD bowl by means of powder transfer system. 3.2 Brief Process Steps The wet mass/ input material will be charged from the PLM to FBD manually The process parameters of the product will be set and verified Subsequent drying takes place Discharge the dry granules into the multimill preferably by using PTS 3.3 Output & Discharging method 3.3.1The powder transfer unit (PTS) should be the part of FBD component and its design should facilate the transfer of semidried /dried mass from FBD/PLM to respective discharging station The dried granules from the FBD bowl are discharged into the multimil preferably through PTS.

6 Page 6 of Productivity Requirement 4.1 Desired/ suggested capacity 250kg Specifications Remarks 4.2 Standard batch size Variable batch sizes 50kg 250kg 4.3 Change Over Time Vendor to give information on change over time from one product to ather Product 4.4 Cleaning/sanitization Time The equipment shall be easily accessible for cleaning the n-product contact part at maintenance side of the equipment Equipment contact parts shall be easily dismantle and cleanable Cleaning of external product n-contact part shall be done manually.

7 Page 7 of Safety requirement 5.1 General Following facilities must be provided to protect personnel, article and equipment: In the event of equipment malfunction or loss of utilities, the unit must contain all necessary protection devices to ensure that the equipment and the article remain in a safe condition Noise level below 75 db at a distance of 1 mtr. from the equipment Emergency stop function on all accessible areas Appropriate failure detection and alarm tification Appropriate closure of all the rotating parts Equipment should be explosion proof Equipment should be supplied with scrubber/any such cost effective arrangement to integrate with exhaust dust so that exhausted powder is t added to the environment Actuated dampers for inlet and outlet. Specifications Remarks Flame proof motors Proper earthing of the equipment. 5.2 Power failure and recovery On power failure equipment shall come to rest, to protect operator, equipment itself and the product Power restart must t be automatic and human intervention must be required.

8 Page 8 of After regain of power the equipment should start from the step it stopped. 6.0 GMP requirements 6.1 Process control The equipment must operate and control the following process parameters Filtered compressed air pressure Inlet air temperature and air flow Product bed temperature Exhaust air temperature control Filter chamber differential pressure SFM (Solid Flow Meter) Automatic filter shake control with the option of setting individual shaking time and pauses Process end All the above settings should be possible to be done from outside without opening The machine 6.2 Failure mode detection Equipment shall be capable to detect the following failure, tify the operator with alarm and shutdown the process: Emergency stop

9 Page 9 of Powder leakage through exhaust system SFG leakages in filter bags and number of fingers in each bag Equipment shall be capable to detect the following failure Pressure Differential: for HEPA Inlet Temperature Product Temperature Exhaust Temperature Operation Air Pressure Minimum. 6.3 In Process control 6.4 Level of instrumentation Sufficient and suitable instrumentation for the process, safety and productivity control as indicated in the following table: Type of control Inlet air Temperature Product temperature Exhaust air Temperature Purpose Monitor and control the inlet air temperature. Monitor and control product temperature. Monitor the exhaust air temperature. Instrumentation PLC HMI PLC HMI PLC HMI Airflow rate. Monitor and control air flow rate PLC HMI Humidity Monitor humidity of inlet air PLC HMI

10 Page 10 of Cleaning requirement All bolts, nuts on the exterior part of equipment will be with cap head or cap nut (SS) Design of equipment should enhance cleaning feasibility by providing minimum sharp corners, minimum crevices & smooth finished welds joints Parts, which are required for cleaning out of place, should be provided with quick fixing. arrangement with TC connection The equipment shall be compatible to different cleaning agents Quick dismantle of Dutch weave mesh All trolley wheels swirl type Procedure for Cleaning of filter bags. 6.6 Qualification requirement General Equipment shall be qualified for design phase (DQ), installation phase (IQ), Operational phase (OQ) and the performance phase (PQ) Vendor shall support client in execution of all the qualification phases. 6.7 Material of construction All following metallic critical contact surfaces should be constructed of 316L grade stainless steel. with internal mirror surface finish < 0.5μm Ra All n-product contact metallic surfaces should be constructed of 304 grade stainless steel, external surface finish as matte finish< 1.2μm Ra.

11 Page 11 of Gaskets, seals and O-rings coming in direct / indirect contact surfaces should be constructed of FDA approved polymeric materials (food grade only.) All welds should be ground finished to < 1.2μm Ra and properly passivated Insulation material should be n-fibrous and covered with completely welded SS 304 or better cladding FBD bag shall be antistatic and n-leachable material Flame proof light arrangement inside the equipment for observing drying process. 6.8 Use of lubricants Any lubricant, used in the equipment must be of food grade and n-toxic. Note :- Mesh size 110 # 6.9 Desired documents Following documents, but t limited to these, are expected from the vendor as part of the supply package Vendor shall supply the document package in phases throughout the life cycle of the project as follows: Phase 1: Preordering of the equipment Filled in URS Equipment layout drawing fitted in the room layout block Detail technical offer that support the compliance of the URS

12 Page 12 of Phase 2: Post ordering and prefabrication stage of the equipment Functional design specification and technical specification, that should contain the following: Equipment descriptions and its function Equipment operation steps List of failure indications List of interlocks List of input/outputs and its functions Specifications Remarks Critical list of major component, devices and instruments with their specific functions, specifications data sheet Schematic diagram of the equipment. Based on the above documents, equipment design shall be evaluated and approved by the user for the fabrication Activity chart of the project Phase 3: Fabrication stage of the equipment Vendor shall provide the FAT protocol at least 1 month in advance of the date of FAT, for the approval by the user.

13 Page 13 of Phase 4: Delivery of the equipment Vendor shall provide the following documents in the delivery package in minimum 2 sets. The delivery package shall reach the site of user atleast 15 days before the delivery equipments for the engineering check of the documents Operation and maintenance manuals, preventive maintenance schedule for equipment major component as well as the operating system Operation and maintenance manuals for the bought out items Installation instructions/ guideline for equipment Final as-built drawing for equipment Detailed drawing marking clearly all the necessary dimensions and locations of utilities along with requirement of utilities on the drawing along with the offer Spare and/ or change parts list with ordering information Certificates for MOC of all direct/ indirect product contact surfaces Types of Lubricant and Lubrication instructions. Food grade Certificate Weld verification report Instrument calibration certificates Guaranty/ warranty certificates for each equipment and major bought-out items, such as PLC, instrumentation etc.

14 Page 14 of Training Training for operators & technical staff has to be included in the offer 6.11 Specific GMP requirement Compressed air used shall be filtered through 0.2-micron filter Arrangements for testing HEPA filters for Integrity should be available Air handling system shall have suitable pre-filtration followed by safe change HEPA filters on supply. AHU shall be located in technical area on the floor above Solid flow monitor / broken bag detector should be included.

15 Page 15 of Technical requirement 7.1 Basic technical requirement A proposal of a possible installation layout should be added to the documentation The manufacturer has to give the clear details on the total weight and the capacity of the equipment The heat given off by the unit must be stated (inside the room and through exhaust) The construction of the complete system should be described in the documentation in detail All revolving parts should be mounted on antifriction thrust bearings Cables, air tubes, etc required from the point (single utility point) to equipment is in scope of vendor Vendor shall provide special tools for maintenance of the equipment 7.2Specific requirements Preferred makes for Motor: Kirloskar / Compton Greaves/ Siemens Preferred make of Pneumatics: Festo The Air handling system shall have safe change on supply as well as exhaust of air to /from the FBD Inlet air handling Unit a) Inlet AHU should be comprised of pre-filter section 10 & 5 micron, cooling coil section, blower section, heating coil (steam heated with face and by pass set up) and 3 micron filter section housed in rigid plenum to provide humidity of less than 45% & temperature < than 25 degree in any ambient environmental condition for the manufacturing of sensitive products. b) The component shall be located within double wall housing with the internal surfaces down stream of the final filter in 316 stainless steel.

16 Page 16 of 18 c) Necessary access door should be provided in the blower section so that the blower, cooling coil and heating coils are accessible for inspection and maintenance. d) All filters should be provided with differential pressure gauges Exhaust Air handling units a) The desired state of fluidization shall be achieved by adjusting the pneumatically operated exhaust air modulating flap. b) The exhaust air blower shall be of antistatic, explosion proof design. c) The exhaust fan is to be protected by the quick acting barrier valves. d) Two stage filter housing with prefilter 10 & 5 micron and 3 micron washable filter with differential pressure gauge Side glass view panel to observe the product Suction charging system should be available Horizontal explosion flap Top dome construction is preferred as single piece construction with inflatable silicone gasket arrangements Two extra bowl with trolley in the supply scope Ten number of spare filter satin bags in the supply scope The MCC panel should be place at service floor and pneumatic panel to be place close to the equipment. 7.3 Utility Requirement Electricity: Consumption details to be provided by Vendor Compressed air: Consumption details to be provided by Vendor.

17 Page 17 of Good Engineering Practices Requirements a. Equipment must be fabricated following all Good Engineering Practices. The vendor s Quality System must follow applicable national standards b. Vendor must generate all applicable documents during all phases of equipment fabrication i.e. design, fabrication, testing and shipment as per applicable standards. c. All sensors, controllers, PLC, transmitters, indicators and will have to be calibrated, Original calibration certificate along with traceability to be submitted by vendor in their IQ file. d. All material of construction should have test certificate e. Vendor must generate and provide all specifications and test certificates of software used in the equipment control and/or monitoring system. 8.1 Inspection and testing a) System shall be inspected and tested (FAT) at the Vendor s site in the presence of user s representative before delivery. b)vendor shall prepare FAT and SAT protocol and get approved from GAPL c) Minimum 3 days shall be reserved for FAT and SAT each and vendor shall ensure the availability of relevant personnel test material and measurement devices.

18 Page 18 of Constraints 9.1 Equipment location and available space This equipment will be installed in the existing available area(ref.2.2) Floor: Ground Floor Department: Tablet Area : Granulation Site visit preferred for the confirmation of exact location for new installation.