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INSTALLATION QUALIFICATIOn Quality NexgenAntibioticzone
INSTALLATION QUALIFICATIOn Quality NexgenAntibioticzone
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.
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.
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.
OPERATIONAL QUALIFICATION
Objective:
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.
SOP and PMP mentioned in the working instruction are followed by the operating personnel,
and SOP provides adequate information to operate the equipment.
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 &
Name
Date Sign