URS For FBD - Pharmainform

User Requirement Specifications (URS) for Fluid bed dyer is as follows,

USER

Pharmainform Pharmaceutical Pakistan

EQUIPMENT NAME

FLUID BED DRYER (FBD)

PREPARED BY

Pharmainform Consultant

Table Of Content

Objective
Scope
Responsibilities
Equipment Description
Technical Requirement
Details of Utilities
Components For Calibration
Alarm & Safety Features
FAT Procedure
Required Documents
Compliance & Data Recordings
Training
Guarantee
FAT Approval

1.0 Objective

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.

2.0 Scope

The Scope of current URS covers,

Design & Construction of FBD.
Installation & Commissioning Of FBD.
Training of personnel for FBD operation, & Its cleaning.

3.0 Responsibilities

User & Manufacturer responsibilities will be,

3.1 User

It will be the responsibility of the user to perform the FAT.

3.2 Manufacturer

3.2.1 Manufacturer responsibility is to design, manufacture & give pre-training on,

Overview of FBD.
Drawings
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

Equipment Name

Fluid Bed Dryer

Purpose

Drying Of Granules

Equipment Capacity

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)

Sr No	Components	Specifications
1	All Contact Parts	SS 316L
2	Non Contact Exposed Parts.	SS 304L
3	Inflatable Tubes	Pharmaceutical grade
4	Elastomers (Seals) in contact with the product	Silicone
5	Elastomers not in contact with the product	Food Grade

5.2 Working Conditions & Safety

Sr No	Item	Specifications
1	Temperature	Ambient 120 °C
2	Pressure	Atmospheric
3	Humidity	Less than 55 %
4	Motor & Blower Fan	Explosion Proof
5	Electricals	Explosion Proof
6	HMI	Water Proof

5.3 Operational Requirements

S.No	Operation	Specifications
1	Charging Of Product	Charging to FBD should be through a pneumatic system. (From RMG)
2	Discharging To Co-Mill	Discharging of dried granules should be through the pneumatic system to the co-mill.
3	Air Processing	AHU must be installed with a heating coil, cooling coil & 3-layer filtration system.
4	Cleaning	WIP/CIP system.
5	Temperature Limits	Inlet Air Temperature 0 to 150°C.
Product Temperature 0 to 90°C.
6	Airflow Volume	500 to 10,000 m³/h.
7	Drying Efficiency	LOD level less than 1 within 1.0 hr.

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.

5.4.3 Filters

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.

5.4.9 SFM

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.

Read Details Of SFM

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.