User Requirement Specifications (URS) for Fluid bed dyer is as follows,
Pharmainform Pharmaceutical Pakistan
FLUID BED DRYER (FBD)
Table Of Content
- Equipment Description
- Technical Requirement
- Details of Utilities
- Components For Calibration
- Alarm & Safety Features
- FAT Procedure
- Required Documents
- Compliance & Data Recordings
- FAT Approval
The objective of this URS is to highlight the requirements of the client for FBD design, and manufacturing of FBD according to cGMP guidelines & to provide a high degree of assurance that the equipment is manufactured according to the requirements of the client.
The Scope of current URS covers,
- Design & Construction of FBD.
- Installation & Commissioning Of FBD.
- Training of personnel for FBD operation, & Its cleaning.
User & Manufacturer responsibilities will be,
It will be the responsibility of the user to perform the FAT.
3.2.1 Manufacturer responsibility is to design, manufacture & give pre-training on,
- Overview of FBD.
- FBD Dimensions
- Specifications of sub-components
- Details description of Utilities
- Calibration Components
- Material Of Construction (MOC )
- Short Working Description
- Safety features
- Requirements for installation
3.2.2 Manufacturer will facilitate the user for Factory Acceptance Test.
3.2.3 Manufacturer will be responsible for the safe delivery of FBD to the client site.
3.2.4 Manufacturer will be responsible for installation, equipment commissioning, and training of staff.
3.2.5 Manufacturer will provide all tools necessary for dismantling & assembling with a toolbox.
4.0 Equipment Description
The FBD is used in pharmaceutical industries for the drying of wet granules. The drying is done by using processed air which is supplied through an air handling unit. After filtration, the air is heated to the required temperature & causes fluidization in the drying chamber to facilitate the drying process. The air leaves the drying chamber after passing through the filters & is exhausted to the environment. The wet granules are charged to the product trolley of FBD by a pneumatic system from Rapid Mixing Granulator. After achieving desired LOD, the dried granules are delivered to the Co Mill/Multi mill by a pneumatic system for sieving purposes.
5.0 Technical Requirements
Fluid Bed Dryer
Drying Of Granules
250 kg Working capacity at 0.5 gm/ml bulk density of powders. (250 kg is the net wet of dried mass without binder solution weight)
5.1 Material Of Construction (MOC)
5.2 Working Conditions & Safety
5.3 Operational Requirements
5.4 General Requirements For Components
5.4.1 Product Trolley
- Made of SS 316L.
- Perforated bottom plate with Dutch weave mesh of suitable size to retain fine powders.
- All internal surfaces must have a smooth mirror-polished appearance.
- The mesh should be fixed with clamps & easy to dismantle for cleaning.
- Side wall-mounted sampling port.
- Product temperature monitoring sensor probe.
- Port for pneumatical delivery of the dried product to Co-Mill.
- Glass view windows to see inside.
- Tilting option for product trolley.
- Product trolley wheels with locking system.
5.4.2 Drying Chamber
- Made SS 316L.
- Glass view windows with lamps to see inside.
- Explosion window Installed according to area layout design.
- Sensors should be installed for monitoring differential pressure.
- SS filters for product retention with suitable pore size. (No Cloth filter)
- Blowback system for filter cleaning during the drying process.
- Easy removal & installation of filters.
5.4.4 Temperature & Airflow Requirements
- Inlet air temperature limit 0 to 150°C.
- Product temperature limit 0 to 90°C.
- Airflow limits 500 to 10,000 m³/h.
- Drying of product to LOD level less than 1% within 1.0 hr.
5.4.5 Discharging System
- Discharging to co Mill should be fast & efficient.
- Ensure 100% product transfer by closing system.
5.4.6 Transfer Pipes
- Pharma grade transfer pipes.
- Ensure smooth product transfer.
- Should not collapse during transfer.
- Easy to clean.
5.4.7 Air Handling Unit
- An air handling unit for air processing must be installed.
- AHU must contain primary,2ndry, and HEPA filters according to guidelines.
- Heating & cooling coils to control humidity & drying temperature.
5.4.8 Exhaust & Blower
- Exhaust air must be filtered before delivering it to the environment.
- The blower & motor must be according to requirements.
- Solid flow monitoring systems must be installed to prevent product loss.
- On detection of filter damage, it must shut down the FBD within 2 sec.
5.4.10 WIP System
Wadh In Place system with the following options,
- Raw water
- Hot water
- Purified water
- Detergent supply system.
- Cleaning spray balls should be installed for cleaning product trolley, drying chamber & filters.
- WIP should be so efficient that no manual scrubbing is required.
5.4.11 HMI & PLC
- HMI (Required brand)
- PLC ( brand).
- Color screen with a sensitive touch system.
- Waterproof HMI & PLC.
- Software installation for PLC & HMI.
- Display of the following parameters on HMI
- Inlet Air Temperature
- Outlet Air Temperature
- Product Temperature
- Airflow Rate
- Differential Pressure
- Humidity level
- During Operation visual diagram of working components.
6.0 Details of Utilities
3 phase (To be discussed)
Compressed air For Sealing
As per requirements.
As per requirements.
To be discussed
7.0 Calibration Components
Identify parts that require Calibration
8.0 Alarm & Safety Features
- Product trolley not in place alarm.
- Filters fitting problem indication.
- Temperature issues alarm.
- SFM alarm.
- Airflow issue alarm.
- Filter choking alarm.
When the fluid bed dryer is ready, the manufacturer will inform the user/client to perform FAT.
10.0 Required Documents
The manufacturer will provide Documents including the following,
- IQ, DQ, OQ, PQ Document
- Manual for Equipment
- Maintenance Manual
- MOC certificate
- Make and model info.
- Electric wires & panel diagrams.
- List of all parts & spare parts.
11.0 Compliance & Data Recording
- Fluid Bed Dryer must be compliant with all regulatory bodies including 21 CFR.
- HMI must store sufficient product data.
- Data printing option.
- Data backup.
- Data transfer by USB.
- Password protection & audit trail.
Manufacturer staff will provide training to the client staff for operating, and cleaning the Fluid Bed Dryer.
The manufacturer will provide a 01-year guarantee for each component of equipment after the commissioning of the equipment.
14.0 URS Approval