Antibiotic Zone Reader Pure Enterprises

ANTIBIOTIC ZONE READER

Design Qualification, Installation Qualification,

Performance Qualification Documents.

Manufactures Name & address User Name & Address

PURE ENTERPRISES Quality Nexgen

114/18, B.D.D. BLOCK , Pharmaceuticals Pvt. Ltd.
WORLI, MUMBAI – 400 018. Gut No. 402,403 Part, 434 part,
Dinkar Pada, post Kondala,
Tal: Wada, Dist: Thane-421 312

Pure Enterprises, Mumbai – 400 018.

Antibiotic Zone Reader Pure Enterprises
INSTALLATION QUALIFICATION
 Objective:

To ensure that the equipment installed confirms to the purchase specification & the
manufacturers literature, and to the document the information that the equipment meets
specifications at
Quality Nexgen Pharmaceuticals Pvt. Ltd.
Gut No. 402,403 Part, 434 part,
Dinkar Pada, post Kondala,
Tal: Wada, Dist: Thane-421 312

 Scope:
To be performed at time of installation, modification or relocation.

 Responsibility:
Person overseeing the installation will perform the qualification & record the information.

This study verifies the following details:-

a) Proper Installation of the unit and examination of all background information
specified.
b) The equipment meets the good Laboratory practices.
c) All Electrical components are properly connected.
d) All test reports, manuals are available on file.

 Description & Identification

a) Name of the Instrument : Digital Antibiotic zone Reader.
b) Make : Pure Enterprises
c) Model No. : PE-27
d) Serial No. :
e) Date recd :
f) Date Installed :

 Specifications of Instrument
 Exterior finish : Powder Coated
 Movement of the platform : Forward & backward manually by rotating side hand
wheels.
 Movement measurement of : Dial Reading on wheel in mm., Range: 35mm,
measurement of dia of Readability : 0.1mm
antibiotic zone
 Lamp Source : Tungsten
 Antibiotic Zone image : Against glass prism mounted in front after reflecting
Visualization light from the reflecting mirror supported in the arm
mounted on the unit.
 3 pin Top : 5 Amp 3 pin top.
 Cord Wire : Polycab 3 core wire
 Power Supply : 230 V AC 50 Hz Single Phase.

Pure Enterprises, Mumbai – 400 018.

Antibiotic Zone Reader Pure Enterprises

 Pre-Installment requirement
 Room free from dust.
 5 Amps 3 pin socket for connection.
 Any samples if possible to check the performance.

The Equipment is properly fitted supported and connected without any difficulties.

All major components are securely anchored from shock. There is no physical damage,
Electric connections are proper and secure they are tight and properly connected. The
following instrument is as per the specifications and acceptable.

Installation Engineer. Installation Checked by

Pure Enterprises, Mumbai – 400 018.

Antibiotic Zone Reader Pure Enterprises

OPERATIONAL QUALIFICATION

 Objective:

To determine that the systems/equipments operates according to specifications and to

record all relevant information & data to demonstrate it functions as expected at.
Quality Nexgen Pharmaceuticals Pvt. Ltd.
Gut No. 402,403 Part, 434 part,
Dinkar Pada, post Kondala,
Tal: Wada, Dist: Thane-421 312

 Scope:
To be performed after installation, modification or relocation after the Installation
Qualification has been completed.

 Responsibility:
Person responsible for operating the equipment will perform the qualification and record
the information.

The purpose of the digital Antibiotic Zone Reader to get direct readings of zone
diameters for simple assay of antibiotic strength. Determines strength of antibiotic
materials by measuring diameters from 0 to 35mm of inhibited zones in Petri dishes.
Agar in Petri dish is inoculated with bacteria, then sensitivity discs are dispensed onto
dish. After incubation, bacterial growth covers dish except for circular inhibited zone
around each disc. Zone diameter is a function of antibiotic strength.

 Operating the Equipment:

To test the control panel and its components and their functions as stated.

 Description of the Control Panel:-

 Digital Display in mm.

 5 Amps main ON/OFF Switch.
 Light source.
 Glass prism.
 Platform movement hand wheel.

 Standard operating procedure:

 Plug in the 3-pin top (5 amps) in a three-pin socket (5 amps) and put it on.
 Put on the mains switch on the mains supply and the Main switch ON on the Control
panel.
 The light source will glow.
 Move the side hand wheel so that dial reading on wheel will be at 0.00mm.
 Put Petri dish having agar-agar on the moving platform such way that light from source
will pass through the transparent or semitransparent portion of the agar-agar then to a

Pure Enterprises, Mumbai – 400 018.

Antibiotic Zone Reader Pure Enterprises
reflecting mirror supported by an arm above the unit. The mirror reflects the light to a
glass prism mounted at the front of the unit and the magnified image of the zone of
inhibitions can be clearly seen on the prism.
 Then measure the diameters in mm, on the dial reading on wheel, of inhibited zones in
Petri dishes against dark sharp horizontal line on the glass prism by moving platform.
 Then take out the Petri dishes & switch of the instruments.

 Preventive measures Procedures:-

 Before plugging the oven check earthing is proper or not.
 Keep clean all glass optics.

SOP and PMP mentioned in the working instruction are followed by the operating personnel,
and SOP provides adequate information to operate the equipment.

Installation Engineer Installation Checked by

Pure Enterprises, Mumbai – 400 018.

Antibiotic Zone Reader Pure Enterprises

This is certify that the Digital Antibiotic Zone Reader, Sr. Manufactured by M/s. Pure

Enterprises, 114/18, B.D.D. Block, Worli, Mumbai – 400 018, has been Installed &

demonstrated dated _____________ and it’s working satisfactory.

For Pure Enterprises

Name Date Sign

For Quality Nexgen Pharmaceuticals Pvt. Ltd.

Name
Date Sign

Pure Enterprises, Mumbai – 400 018.