USER REQUIREMENT SPECIFICATION FOR

“PHARBACO”
EQUIPMENT

Title:

Microbiological Air Sampler

Doc. No URS-XXXXX As per FRM - XXXXX Page 1 of 6

USER REQUIREMENT SPECIFICATION

FOR
MICROBIOLOGICAL AIR SAMPLER

Introduction in Name sirname, Position Date Signature

Prepared by

Reviewing by

Agreed by

Approved by
 USER REQUIREMENT SPECIFICATION FOR
“PHARBACO”
EQUIPMENT

Title:

Microbiological Air Sampler

Doc. No URS-XXXXX As per FRM - XXXXX Page 2 of 6

CONTENTS

1. PURPOSE..........................................................................................................................................3
2. EQUIPMENT/SYSTEM DESCRIPTION......................................................................................3
3. REQUIREMENTS TO THE PRODUCT AND/OR PROCESS....................................................3
4. REQUIREMENTS TO THE INSTALLATION.............................................................................4
5. REQUIREMENTS TO THE FUNCTIONING..............................................................................4
6. REQUIREMENTS FOR HEALTH AND SAFETY.......................................................................6
7. REQUIREMENTS TO THE VENDORS.......................................................................................6
8. ABBREVIATIONS...........................................................................................................................6

History of the document

Rev.№ Date Reason for change
1.0 New document.
 USER REQUIREMENT SPECIFICATION FOR
“PHARBACO”
EQUIPMENT

Title:

Microbiological Air Sampler

Doc. No URS-XXXXX As per FRM - XXXXX Page 3 of 6

1. PURPOSE
This document is generated in order to specify the requirements for a Microbiological Air Sampler
to be purchased and installed in the Quality Control Laboratories of “Pharbaco”.

2. EQUIPMENT/SYSTEM DESCRIPTION
The Microbiological Air Sampler is a high-performance instrument based on the Andersen air
sampler: Air is aspirated through a perforated lid and impacted onto the surface of growth media in
a standard 90 mm Petri dish or 60 mm contact plate. Micro-organisms are trapped on the culture
media, and after the incubation period the formed colonies can be counted.
The sample should have high airflow accuracy with mass flow sensor to measure the inflow of air
and to continuously regulate the aspirated air volume during sample collection to maintain a
constant value of 100 liters/min ± 5.0%.
The instrument is an active microbiological air sampler, working on the impaction principle. By this
principle, a predefined volume of air passes through the small holes of the sampling head.
Sampling volumes can be configurable between 1 and 2,000 liters. The units should have a
horizontal air flow velocity of 0.45 meters per second and isokinetic flow rate that will not produce
turbulence in a laminar flow environment.
The Microbiological Air Sampler should be powered by a rechargeable battery
The microbial air sampler should features a USB data communication port.

The Microbial air sampler should comply with ISO 14698-1, ISO 14698-2 and ISO 14644-1, Class
5 (Unidirectional flow – follow the guideline of cleanroom), EU GMP guideline

For measurements in the pharmaceutical industry the recommended sampling volume – according
to international guidelines – is 1'000 liters
Service and calibration of the instrument are straight forward. All settings and parameters of the
instrument can be programmed via the PC software.
The equipment should include the de – pressure tool for sampling compressed air and nitrogen
system

Certificate of Origin (CO): European

3. REQUIREMENTS TO THE PRODUCT AND/OR PROCESS

3.1. Annual Production Capacity – Microbiological Air Sampler will be used in the Quality
Control Laboratories at two-shift regimen of work 24 working hours, 7 working days a week, whole
year.
3.2. Main criteria for the design – to observe the requirements of the Viet Nam and the European
Union regulatory authorities for the production and control of medicinal products.
4. INSTALLATION REQUIREMENTS
 USER REQUIREMENT SPECIFICATION FOR
“PHARBACO”
EQUIPMENT

Title:

Microbiological Air Sampler

Doc. No URS-XXXXX As per FRM - XXXXX Page 4 of 6

Requirement Specification
Location Quality Control Laboratories at Pharbaco

Size & Dimension Should be convenient for portability

Cleanliness The equipment will operate in various cleanliness class (from A to D) in

Classification: Pharbaco
Physical connection to USB interface, RS-232 to other systems
other equipment
Power supply Should be able to operate with electric power in Pharbaco
The Microbial Air Sampler must meet the requirements of the Viet Nam and
the European Union regulatory authorities for control in the production of
Other
medicinal products. The supplier takes part in all activities related to the initial
Requirements:
installation and validation of the device.

5. OPERATIONAL REQUIREMENTS

Requirement Specification
The system is a precise, reliable and cost-effective air sampler which is used to
Capacity detect any airborne micro-organisms and fully complies with the ISO 14698
standard parts 1 and 2.
Principle: Plate Sampler
Flow rate: default 100 L/min (auto-regulated, flow sensor)
Impaction speed (dependent sieve): < 20 m/s (lid 300 x 0.6), <11 m/s (lid 400
x 0.7)
Volumes: 5 preset or individual (1-2000 Liters)
Timer: 1 to 120 minutes
Interval Sampling: up to 24 hours
Material of dust cover, perforated lid, sampling head & body: aniodized
Process Requirements aluminum
The perforated lid and the dust cover can be autoclaved for 20 minutes at
121°C.
Alternatively, the perforated lid and the dust cover can be dry-decontaminated
at 180oC during 60 minutes.
Operation: Key pad, illuminated, easy navigation display
Instrument precision +/-5.0%
Indication of low airflow, Unidirectional flow
Calibration: automated calibration with DA-100 NT
 USER REQUIREMENT SPECIFICATION FOR
“PHARBACO”
EQUIPMENT

Title:

Microbiological Air Sampler

Doc. No URS-XXXXX As per FRM - XXXXX Page 5 of 6

Requirement Specification
Ambient Conditions Operation: 5°C to +45°C
Up to 2000 m above sea level
The Microbial Air Sampler will be used in the Quality Control Laboratories at
Availability
two-shift regimen of work 24 working hours, 7 working days a week, whole
Requirements
year.
The PC software is a communication & calibration software for the portable
air sampler. The main scope of the PC software is programming the instrument
and reporting the sampling results.
The functions of the instrument can be programmed directly via the
Control System instrument’s operating and display elements (HMI) or by means of the PC
including HMI User software.
Interface Specific Templates for sampling plans and inspection protocols can be generated
Requirements easily. The instrument can transfer up to 100 test results, which are allocated
to up to 10 different users, to the PC software for evaluation and reporting. For
this, the instrument can be connected to a PC by means of a USB cable.
Sample and alarm logs can be read from the instrument and can be stored or
printed to guarantee for full traceability of the results.
Password protected: This function blocks manual interventions on the
Other Requirements instrument. The only accessible functions on the instrument are now reduced
to starting and stopping a sampling and the user has only read access.

6. HEALTH & SAFETY REQUIREMENTS

Requirement Specification
Containment or Not applicable
Explosion Protection
Needs
Noise Level None
Constraints

7. VENDOR REQUIREMENTS
VENDOR REQUIREMENTS
- Installation of the equipment;
- Initial qualification on client site;
Vendor activities
- Training of personnel;
- Commissioning
 USER REQUIREMENT SPECIFICATION FOR
“PHARBACO”
EQUIPMENT

Title:

Microbiological Air Sampler

Doc. No URS-XXXXX As per FRM - XXXXX Page 6 of 6

VENDOR REQUIREMENTS
-Operating and maintenance user manual;
-Declaration of conformity;
Vendor -Test certificate;
documentation -Validation support package IQ/OQ for the equipment;
-Protocols from test execution on client site;
-Spare parts list;

8. ABBREVIATIONS
IQ: Installation qualification
OQ: Operation qualification
PQ: Performance qualification
CE mark – mandatory European marking for some product groups which is to demonstrate the
compliance with the requirements for health and safety, set in the European directives.