Purpose

This User Requirement Specification (URS) is written to convey the technical documentation and installation
requirement of Fluid Bed Dryer (FBD), to be used as a new equipment in the grey room of PT. Sinkona Indonesia
Lestari - Subang. This document has been produced to enable a quotation to be sort for a FBD that meets the user
requirements detailed within this specification.
This FBD was purchased for replacement of Dryer (Oven).

Scope
This URS applies to the whole process of specification, purchase of material and process of installation.

Out of Scope
This following items are out of scope from this URS:
- Compressed air
- Clean / Plant Steam

Overview
Process/System Description
This equipment used for drying process with working capacity 100 kg (30 – 110 kg), with single shaking operation. This
equipment is designed for bulk density within the range of 0.5 – 0.6 g/mL.

Design
Safety Proof System
Horizontal explosion Proof type (EG3 Type) made of SUS 316.
 Explosion proof type of low : -1 – 0.6 Kg/cm2
(Pressure Diaphragm, Brand: WIKA or equivalent).
 Explosion proof type solenoid valve : MHF-5-1/2 (Brand: Festo or equivalent)
 Pressure accumulator : VZS-10 (Brand: Festo or equivalent)
 Pressure gauge : Ø60 mm (Brand: Festo or equivalent)
 Quick exhaust valve : SEU-3/8 (Brand: Festo or equivalent)
 Motor : EG3 Type

Filtering System
 Pre Filter : Polyester Cloth & AL

 Final Filter : P.A.O 95 % 0.3µ (Brand: Kowa or Equivalent)

 HEPA Filter : For air inlet, P.A.O 99.97 % (H13) 0.3µ, Air flow 37.5 CMM for each
(Housing made of SUS 316)
 Manometer : 80 mmHq (Brand: Dwyer or equivalent)

Heating System
 Heating system by plant steam, temperature is controlled by modulating (PID, brand control valve: Burkert).
 Heating & filter case : made of SUS316

Exhaust System
 Exhaust blower : 25 HP (Brand: TECO or equivalent)
 Air flow : 70 CMM
 Static Pressure : 800 mmHq
 Emergency stop : (red button)) interlocking type (Brand: Telemecanique or equivalent)
 Exhaust duct : made of SUS316
 Elbow : made of SUS316
 Air Damper : Proportional Control (Brand: Festo/YCT or equivalent)

Unit Control System

 Control panel made of SUS 316
 Manometer for container and bag filter (Brand: Dwyer or equivalent)
 Exhaust Static Pressure Meter : 612.20 4"DT3/8”, 0~1000 mmH2O
 Indicator Lamp : SLC30-2row*13pcs 220V
 Voltage Meter : EFA-72 0 ~ 600V
 Ampere Meter : EFA-72 0~100A, 50/5A
 Digital Timer for mixing time, drying time, pause time, and shaking time. (Brand: Omron or equivalent)
 Emergency Stop: (Red) Interlocking Type (Brand: Telemecanique or equivalent)
 Lock Out Tag Out Switch
 Pressure Switch (Brand: Festo or equivalent)
 Solenoid Valve for damper, shaking device, container up/down, and bag filter lifting. (Brand: Festo or equivalent)
 Air electricity convertor, Pressure regulator, Compress air service unit and Compressed air filter. (Brand: Festo or
equivalent)
 Temperature Controller (sensor: PT 100Ω) for air inlet, outlet and product temperature. (Brand: Omron or
equivalent).

Operation Interface
 Touch Screen, compliance to data storage regulations and data receiver by Pen Drive card in Photo format (Brand:
Siemens or equivalent)
 Resolution: 640 x 480 pixels
 Monitor: 10 inch color LCD
 PLC (backup power: battery, etc) (Brand: Omron or equivalent), programs:
- Password system
- Alarm data setting system
- Master setting system for all parameter data setting
- Manually production process
- Automatically production process (recipe recording process record)
- Backup power (e.g.: battery) need to confirm to vendor

Commissioning
 I/O Test
 IQ/OQ
 Pressure test to meet containment requrement (seals integrity)
 Product test
 Training (max. 2 times): for Production Operators, Production Supervisor, Maintenance Technician Staff.

Documentation
Documentation to be supply (bundling in Technical Document):
 P&ID and mechanical drawing for all tanks
 Operating manual book
 Machine layout
 Wiring diagram
 Electrical part list
 Mechanical part list
 Maintenance manual book
 Design Qualification (DQ) report
 Installation Qualification (IQ) report
 Operating Qualification (OQ) report
 Spare part list
 Calibration report for all indicator gauge, temperature
 Certificate of HEPA filter
 Certificate of Bag Filter
 Welder certificate
 Welding map drawing and report
 Material certificates (material analysis) for all product contact
 FAT/SAT Protocol
 Heating test and report
 Pressure test and report
 Passivating procedure and report
 Roughness report
 Piping layout for PW, steam and compressed air

Operational Requirements
The Operational requirements for the system are defined in the sections below:
Critical Quality Attributes (CQA)

Requirement CQA Units Control Limits

The output of the drying system/equipment must

conform to the critical quality attributes as Moisture analysis value % 3–5%
defined specification

Product Density Bulk Density g/ml 0.5 – 0.6 g/ml

The temperature of the inlet must conform to the

Temperature °C Up to 100°C
critical quality attributes as defined specification
The temperature of the outlet must conform to
the critical quality attributes as defined Temperature °C Up to 70°C
specification

Process/Functional Requirements
Provide details of the process requirements, unit, accuracy and control limit. The measurement accuracy required
should be added for each parameter which influences instrument selection/specification and calibration requirements.
The required control limits should also be added which again influences the instrument selection/and calibration
requirements downstream
The following table defines the specific process requirements for the system.

Process Requirements Control Limit

The Supplier must guarantee the following process requirements from their
N/A
FBD
 Set up time NMT 5 minutes

Drying time estimation (depend on product formulation)

Cleaning time NMT 60 minutes

Cleaning Process Requirements
Critical parameter of the WIP requirements
1. The FBD must be made easily cleanable by design (especially for product contact parts), and should be
challenged in cleaning validation program, as required by cGMP.
2. The equipment must be designed for easy and repeatable cleaning with no potential product or water traps and
fittings that are easy to take apart and re-assemble if required.

Drying (After cleaning or washing) Process Requirements

The inside of body FBD, Container and Filter Bag

Sampling Requirement
Sampling port is located on side of the container

Buildings and Facilities

 Design and Construction
- Architectural Requirement
1. The room that available:
Drying Room (LxWxH); 8 x 5 x 4 meters
This room use for placing Fluid Bed Dryer
2. The general wall finish should be smooth and non-shedding
3. Type of construction of the equipment defined in this specification must conform to Current Good
Manufacturing Practice for finished pharmaceuticals.
4. Type of construction of the equipment defined in this specification must conform to FDA regulations and
guidelines, as may be applied to this type of equipment including design codes and relevant testing as
agreed between the Customer and Supplier.

- Designated Areas / Storage Requirements

A designated area for storage of selected material need to be locked and given restricted assess

 Utilities (HVAC, Water, Compressed Air, electrical, steam, etc)

- Process Utility Requirements (HVAC, water, clean compressed air)
1. Process room must meet class 3,520,000/ m3 requirement
2. Process room must equipped with tap water for cleaning purposes
3. Process room must equipped with USP purified water for process purposes
4. Process room must equipped with clean steam for heating process purposes.
5. Process room must equipped with clean compressed air for cleaning purposes
(for spraying process purposes, the capacity must be enhanced).

- General Utility Requirements (steam, chilled water, instrument air, electrical, etc)
1. Compressed Air Consumption: 5 Kg/cm2 1200 NL/min
2. Clean Steam Consumption: 3 Kg/cm2 180 kg/hr
3. Power Consumption: 380V 3 Phase 50Hz, 20kW
 - People/Material Flow Requirements
The flow of material through the facility should be such to prevent mix up or cross contamination (ICH Q7a
4.13).

 Waste and Disposal

Container and/or pipes for waste material should be clearly identified (ICH Q7).

Process Equipment
 Design and Construction
- Equipment Selection
1. The process contact materials of construction of the equipment should be such as to not alter the quality
of the intermediate / API beyond its established specification (ICH Q7a 5.11).
2. Any product contact parts should be made of a single piece of 316L stainless steel (max 0.8 Ra, with a
finish of 240 grit) or non-fibre shredding materials or materials that can react with or absorb anything from
the products (e.g. Flavourings). There must be no joints or crevices that could be water or product traps
with all finishes flush to the surface.

- Surface Finish Requirement

1. Surface finishes for individual plant units, including process contact and non-process contact surfaces.
2. Cleaning of surfaces

- Certifications
1. All materials that direct or indirect product contact in processing to be supplied with materials of
construction certification. Body of machine and container, bag filter and seal.
2. All processes of welding should be conducted by profesional resource who has the welder certificate.

- Incidental Contact Substances

1. Food grade lubricants and oils should be used where possible (Ref. ICH Q7a 5.14)
2. The design should be such that lubricants or coolants do not contact the process (ICH Q7a 5.14).

- Maintenance Calibration and support Requirement

The machine must be easy to maintain in terms of routine inspection and replacement of faulty or worn parts
and automatically checked for correct operation regularly.

- Environment, Health and Safety Requirements

1. The installation should comply with current applicable pressure regulation requirements
2. During the operation of this system, noise levels must not exceed 80dB (A)-measured 1 metre from the
equipment, when running components at the maximum stated output.
3. Machine will not operate unless emergency stop push-buttons are withdrawn and all moving parts must
be properly guarding.
4. Doors/cover for moving parts must be installed with interlock system. No sharp edges that potentially
injure the operator and Put safety sign for hazard areas/points.
5. Explosion proof ducting provided just in case there is explosion.

 Supplier Deliverable/Support Requirements

- Supplier Capabilities
 1. The vendor must follow a proven implementation methodology and be capable of providing resource and
expertise to assist in deploying the system.
2. The Supplier will be contracted as the principle contractor for supply & installation of equipment as
specified in this URS. The principle contractor will be responsible for programming & instructing all works
to be carried out by others.
- Supplier Testing
1. The Supplier should facilitate or complete FAT on behalf of Sinkona Indonesia Lestari.
2. The Supplier shall include for installation and commissioning during normal working hours.
3. The Supplier has the following responsibility to ensure that works achieve practical completion within
programmed time.

- Supplier Test Documents

1. Supplier should provide (D/I/O) qualification.
2. The Supplier has the following responsibility to fully document the control requirements for the equipment
under his supply.
3. The Supplier has the following responsibility to perform and document all such mechanical testing of
plant and equipment.

- Supplier System Delivery

1. Operating manuals must be supplied as part of the system delivery.
2. The Supplier has supplied all documentation specified within this document for operation, maintenance
and subsequent validation of the equipment under his scope of supply to the quality required.

- Supplier System Support

1. The vendor must offer a training package for all users of the system, including technical support users.
2. The Supplier must support all equipment items for a minimum of 10 years, as specified by EU
regulations.
3. The Supplier must ensure that suitably trained staff are used on this project, familiar with the standards
required for the pharmaceutical industry.
4. The Supplier has provided adequate training to Sinkona Indonesia Lestari staff in the use and correct
operation of the equipment in accordance with this specification.
5. The Supplier has the following responsibilities to fully support the Engineer and/or nominated sub-
contractors in the commissioning of the equipment.

 Computerised System Requirement

- Operations
1. Start Up
On initialisation of the system all control modules must default to their fail-safe position.
2. Shutdown
Shutdown of system components (e.g. Servers, PCs) must be controlled physically and/or logically.
3. Automatic and Manual Operations
The system must allow automatic and manual operation of control modules
4. System functions (Modes of Operation)
5. Non-process related activities
All equipment and operations must have the facility to be held and or released from the control system to
allow cleaning and maintenance.
 6. Alarm Handling
6.1. Alarms must be logged to a historical viewer that can be easily accessed by the user.
6.2. The product container must be supplied with non-intrusive differential pressure sensors, visual
indictor & max level alarm across the retention screen.
7. Event Handling
7.1. All events generated by the system must be captured and electronically logged chronologically to
the event database on a hard disk on one or more designated workstations and stored.
7.2. System is supported with internal/ eksternal memory with capacity .. GB and estimated for... days.

- Control System Interfaces

1. Operating Environment
Hardware must be located in a dry cool place
2. Display Modes
Equipment operated with help of HMI
3. Display Parameters
Operational parameter must capture on HMI
4. Manual Intervention
4.1. Equipment must cover manual shutdown
4.2. The positioning of additional emergency stop buttons must be agreed with the customer as part of
the design reviews.
5. Hardware
5.1. Equipment must have switches that easy to operate.
5.2. All sensor connections should be plug and socket type to aid maintenance.
5.3. The PLC and Operator interface should have a filtered power supply.

- System Access, & Security and Data Integrity

1. Physical Security
Access to control panel must be controlled and locked
2. Logical Security
2.1. Equipment operation using different level of password
2.2. The PLC program should be held in battery backed RAM
2.3. Restricted access must be provided for access to maintenance & cleaning functions from the PLC
3. Data Integrity
History log from operation parameter must be recorded and keep for defined period

- Data / Record Handling and Reporting

1. Regulated Electronic Records (RER)
1.1. The system must be compliant with the Security requirements of ‘21 CFR Part 11 ‘, 91/356/EEC
Annex 11.
1.2. Any system that uses data held in memory, must not lose this data in the event of a mains failure
2. Regulated Electronic Signatures (RES)
The system must be compliant with the Security requirements of ‘21 CFR Part 11 ‘, 91/356/EEC Annex
11