USER REQUIREMENTS SPECIFICATION

(URS)
Document Title: User Requirements Specification (URS)

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Project: Counter Pressure Lab Autoclave

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USER REQUIREMENTS SPECIFICATION

(URS)
Document Title: User Requirements Specification (URS)

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Project: Counter Pressure Lab Autoclave

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Table of Contents
REVISION HISTORY..........................................................................1
DOCUMENT REVIEW & APPROVAL:....................................................1
1.0 INTRODUCTION........................................................................... 3
2.0 SCOPE.......................................................................................3
3.0 GENERAL GUIDELINES.................................................................3
4.0 OVERVIEW SECTION....................................................................4
5 OPERATIONAL REQUIREMENTS SECTION..........................................5
6 CONSTRAINTS...............................................................................8
1. LIFE CYCLE................................................................................... 8
8 GLOSSARY................................................................................... 10

USER REQUIREMENTS SPECIFICATION

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Document Title: User Requirements Specification (URS)

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1.0Introduction
This document was produced by the Lab department. The purpose of this
document is to define the User Requirement Specifications (URS) for the
Counter Pressure Air Mixture Lab autoclave used to sterilizing of vial, bottle
and softbag at Lab Facility. References to GMP guidelines, are listed in the
reference section.

2.0Scope
The system used to Sterilize vial with cap of size 20 ml, bottle with cap of
size 50 ml, 100 ml, 250 ml and 500 ml and softbags of 100 ml, 250 ml, 500
ml and 1,000 ml in the Lab Facility. This system will be identified as a
whole at this location as system number 12345, with all major pieces of
equipment identified as subsets of this system number.
The product to be process are FAT Emulsion, Propofol IntraVenous and True
Aqueous Solution
It is realized that the actual system may not fulfill all of the requirements
and may also include additional functions / features not detailed within. To
this end, this documents purpose is to enable the supplier to generate a
detailed Functional and Technical Requirement Specification that will
then be used as the key design specification for the life of the project.

3.0General Guidelines
A URS defines, clearly and precisely, what the user wants the system to do.
It defines the functions to be carried out, the data on which the system will
operate, and the operating environment. The URS defines also any
non-functional requirements, constraints such as time and costs, and what
deliverable are to be supplied. The emphasis should be on the required
functions and not the method of implementing those functions.

USER REQUIREMENTS SPECIFICATION

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Document Title: User Requirements Specification (URS)

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4.0Overview Section
This Section shall give an overview of the system explaining why it is
required, and what is required of it. It shall contain the following subsections:
4.1 Background
Pharmaceutical Company with the capacity to manufacture clinical and
commercial product. Part of the Research and Development process
involves filling product vials/bottle (liquid) and softbag in the Lab Scale are
sterilized with Counter Pressure Air Mixture Autoclave to be simulated to
have the same result as per actual Production Facility.
4.2 Key Objectives and Benefits
Counter Pressure Air Mixture Lab autoclave is a Steam sterilizing of glass container and
softbag which ensures the removal of at least 6 log reduction challenge with biological
indicator ref. Bacillus Stereothermophillus, where Z=10C, D= minimum1 minutes,
T.Ref=121C and achieve Fo minimum 15 minutes at coldest point with counter pressure to
protect the flexible deformable container from bursting.
4.3 Applicable GMP Requirements
This system is to be designed installed to assist to meet the following GMP
requirements:
4.3.1 Volume 4 EU Guidelines to Good Manufacturing Practice Medicinal
Products for Human and Veterinary Use Annex 1 Manufacture of Sterile
Medicinal Products
4.3.2 PIC/S Guide to Good Manufacturing Practice for Medicinal Products, 2006
4.3.3 Indonesian cGMP, 2006 Edition, Jakarta 2006
4.3.4 CE Requirement
4.3.5 OSHA Regulations
4.3.6 HTM guideline for Sterilization UK

USER REQUIREMENTS SPECIFICATION

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5 Operational Requirements Section

The system must be capable meeting the requirements addressed in the
following section.
5.1 Functions
5.1.1 There's an access limitation to change critical control parameter
(password access comply to 21 CFR Part 11)
5.1.2 Machine is design to make supervisor/regulatory easier to do the
supervision
5.1.3 Phase change should be controlled all products temperature sensor and
drain temperature Sensor.
5.1.4 Other Features as per EU/FDA guidelines.
Note: It is realized that the actual system may also include additional
functions / features not detailed within. To this end, this documents purpose is
to enable the supplier to generate a detailed Functional Requirement
Specification and the Quotation that will then be used as the key design
specification for the life of the project.
5.2. Construction
5.2.1 Vertical Loading with movable wheel.
5.2.2 Product container contact surface should made of AISI 316L or other part
with already FDA Approved that wont be corrosion/rusty during
sterilization process & doesnt release particle
5.2.3 Surface connected with critical area should be design to simplify in
cleaning (no ledges, no non cleanable gaps) and sanitation/easily
removed to clean up.
5.2.4 All contact parts with product to be constructed of materials that are
chemically inert and non shedding over the entire range of process
condition (temperature, pressure, etc)

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5.2.5 Machine can be operated properly as plant operating schedule : 3 shift x 7

days x 1 months for years based on production schedule.
5.2.6 Machine should be designed easy to installed, activities, calibration and
maintenance.
5.2.7 Sub system from machine that could be source of particle contamination
should be design that it wont cause contamination
5.2.8 Spare part which is installed in machine must be standard and easy to get
in the market.
5.2.9 Machine should have its own Steam Generator, vacuum pump and also
jacketed for cooling and pre heating.
5.2.10

Change parts designed for fitting and removing with minimum use

of tooling
5.2.11

Machine is design to make supervisor/regulatory easier to do the

supervision
5.2.12

Moving parts should be contained in housing that prevent exposure

to chamber
5.2.13

Machine can be fully drain the water in the chamber if needed

5.2.14

Internal finish of Ra < 0,4 micron with internal electropolish finish

5.2.15

Sanitary tubing & fitting according to ASME BPE-2002 conform to

ASTM A269/A270
5.2.16

Gasket & other contact part must conform to ASTM A269/A270 or

ASME BPE 2002

5.2.17

Used sanitary tri-clamp connections and fittings SS316L

5.2.18

Used sanitary vacuum pump conform to ASTM A269/A270

5.2.19

Piping is sloped to be self-draining, with elimination of dead legs

5.2.20

Design of Loading baskets should consider easily handling and

operation.
5.2.21

Easy Opening and Closing system.

5.2.22

Insulation system to protect the operator and environment.

USER REQUIREMENTS SPECIFICATION

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5.3. Instrument
5.3.1 Instruments to be positioned so as to indicate true representative value
for process parameter
5.3.2 Installed instrument/sensor should be easy to uninstall/installed to make
routine calibration easier or ease to replace the instrument/sensor when
became degraded
5.3.3 Installed sensor is designed to simplify/easier to calibrate (all instruments
are fitted with calibration system)
5.3.4 Instrument direct contact with the product or associated with critical
manufacturing process must also be designed and installed to:
1. Prevent accumulation of any matter
2. Withstand required cleaning/sanitization process and agents without
degradation
3. Not present a contamination risk to the product or its excipients
4. Not be degraded (physically or in performance) by contact with the
product, its excipients or the processes to which it is subject
5.3.5 Install USB port/printer for sterilization autoclave which contain
minimum :
1. Detailed and full description of production process include: Production
area, Product Name, Product Batch No, Set Temp, Name of Operator,
etc
2. Contain Date and Time (Start Time, Batch Time, Sterilization Time)
3. Values of Temperature for Each Temperature Sensor on The Equipment
(show on the graphic)
4. Non Editable
5. Values of Pressure for Each Pressure Sensor on The Equipment (show
on the graphic)
6. All critical parameter

USER REQUIREMENTS SPECIFICATION

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5.3.6 Minimum 1 Temperatures sensor for monitoring, controlling & recorded of

temperature inside the product.
5.3.7 Install chamber drain temperature
5.3.8 Pressure Gauge for monitoring & recorded pressure in the chamber.
5.3.9 Door Locking according to DIN by pressure switch and safety device for
hot opening.

5.4. Performance
5.4.1 Efficiency of Sterile Filtered Air : Show the integrity of 0,2 um (If drying
process using air filter)
5.4.2 Equipment reliability: 97% available excluding scheduled maintenance
shutdown.(Optional)
5.4.3 Dead Legs < 1,5D according to WHO TRS 937.(Optional)
5.4.4 Welding seams comply to ASME BPE 2002 Regulation (Welding on the
material which contact with the product).
5.4.5 Weld Discoloration Level inside the Pipe : Maximum level 3.(Optional)
5.4.6 Heat Distribution Variation on Empty Load and Full Load Condition: 121C
122.5C.
5.4.7 Heat Penetration (Fo Value): Minimal 15 minute at temperature 121C on
the coldest point.
5.4.8 Microbiological Reduction : Minimal 6 Log Reduction, challenge with
Biological Indicator challenge with Biological Indicator (Bacillus
Stereothermophilus: 10^6 CFU/Ampoule).
5.4.9 Can able to run Steamand Air mixture cycle and without Air mixture cycle.
5.5. Capacity
5.5.1 Minimum Useful volume

USER REQUIREMENTS SPECIFICATION

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80 Ltrs

Include Basket.

6 Constraints
6.1 Timescales
The system shall be installed, commissioned and validation testing started
no less than 6 months after the order has been submitted
6.2 Availability
The facility will be made available for contractor access minimally at the
following times: Monday Friday 8am 4pm (Off hour access can be made
available upon request)
6.3

Maintenance
All supplied equipment must be supplied with 24 months or 4.000 working
hours warranty period from the time of system acceptance from the
supplier.

1. Life cycle
The proposed system must be designed, produced, installed, tested and
supported in accordance with Applicable cGMP Requirement at point 4.3
7.1 Development
The development of the software shall have a defined, auditable
methodology. Procedures for project management, quality assurance shall
be documented. Standard design methods and documentation control shall
be in place for the supplier.
7.2 Testing
The system must be fully tested as per cGMP.

USER REQUIREMENTS SPECIFICATION

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7.3 Delivery
Delivery of all items are to be documented with packing lists, signed by the
P.T.Bernofarm. Below is a list of the key expected deliverable from the
supplier:
7.3.1 Equipment

Installed Power ??? KW

Steam Generator
Vacuum Pump to remove Air
All of sensor in the point 5.3
Sound Emission Level < 80 dB
Mechanical and Electrical component based on detailed design
specification
Electric board and operator interface unit:
1. Integrated in one unique electrical cabinet, which also include
two touch screens for all process
2. Electrical cabinet made from SS304 which a scotchbrite
finishing
3. HMI/Operator interface by SIEMENS
4. PLC Siemens
5. Diapharm Valves (GEMU)
Jacketed for Cooling and Heating.
Utility Requirement
Support Pressure with Pressure Indicator and Safety valve.

Note: it is realized that the actual system may also include

additional detail design not detailed within. To this end, this
documents purpose is to enable the supplier to generate a detailed
Design Specification and the Quotation that will then be used
as the key design specification for the life of the project.
7.3.2

Documentation (Optional)
Operation and maintenance manual include system and panel
layout and wiring drawings
List of instruments
List of control alarm
Electrical & Mechanical Drawings per Components
P&ID Include:
- Identify all component with appropriate tag numbers
Calibration procedure and test certificate all the instrument on
the equipment (original)

USER REQUIREMENTS SPECIFICATION

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7.3.3

Material test certificate components which contact with product

Functional requirement specification
System/detail design specification
System Installation

Site Services (Optional)

7.3.4

System training.

Activities:(Optional)

Task
Final user requirement
specification
Quality and project plan

By
Infion
Supplier

Functional requirement
specification
System/detail design
specification
System drawings and panel
layout (P&ID Drawing)
System installation

Supplier

Operation and maintenance

manual
IQ Docs

Supplier

IQ tests

Supplier

OQ Docs

Supplier

OQ tests

Supplier

Training:

Supplier

Project completion

Supplier

Supplier
Supplier
Supplier

Supplier

Format
Hard Copy &
Electronic
Hard Copy &
Electronic
Hard Copy &
Electronic
Hard Copy &
Electronic
Hard Copy &
Electronic
Hard Copy &
Electronic
Hard Copy &
Electronic
Hard Copy &
Electronic
Hard Copy &
Electronic
Hard Copy &
Electronic
Hard Copy &
Electronic
Hard Copy &
Electronic
Hard Copy &
Electronic

USER REQUIREMENTS SPECIFICATION

(URS)
Document Title: User Requirements Specification (URS)

Rev : 0

Project: Counter Pressure Lab Autoclave

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Date:
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Glossary

cGMP

Good Manufacturing Practice

ISPE

International Society for Pharmaceutical Engineering

QPP

Quality Project Plan

FRS

Functional Requirement Specification

SDS

System Design Specification

IQ

Installation Qualification

OQ

Operational Qualification

PQ

Performance Qualification

PID

Proportional Integrated derivative

P&ID

Pipping&Instrument Drawing

HTM

Health Technical Memorandom- UK

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