Digital Incubator Pure Enterprises

DIGITAL INCUBATOR

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.

Digital Incubator 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 Incubator
b) Make : Pure Enterprises
c) Model No. : PE - 5
d) Working Size : 35 cmW x 35 cmD x 35 cmH
e) Serial No. :
f) Date recd :
g) Date Installed :

 Specifications of Instrument

 Chamber Size : 35 cmW x 35 cmD x 35 cmH.

 Weight
 Material of Construction
 Exterior finish
 Insulation Material
 No of Shelves
 Temp Range
 Temp Controlled by
 Heater
 Location
 Mains Switch
 3 pin Top
: 7 kgs.
: Inside St. Steel. Exterior: Galvanized Sheets.
: Powder Coated
: Glass wool
: 2 Nos.
: 5oC above ambient to 60oC
: Digital temperature controller with PT 100 as sensor.
: Air heater 500 Watts.
: Room free from dust
: 10 Amps Circuit breaker
: 15 Amp 3 pin top.

Pure Enterprises, Mumbai – 400 018.

Digital Incubator Pure Enterprises
 Cord Wire : Polycab 3 core wire
 Power Supply : 230 V AC 50 Hz Single Phase.

 Pre-Installment requirement
 Room free from dust.
 Cross Air ventilation.
 15 Amps 3 pin socket for connection.
 Smooth base to keep the incubator on it.
 Any samples if possible to check the performance.

 Description of the Control Panel:-

 Digital Temperature Controller.
 10 Amps main Switch.
 Mains indication lamp.
 Heater indication lamp.

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.

Digital Incubator 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 Incubator is to study Bacteriological. applications and other test
demanding constant & uniform temperature above ambient to 60 oC

Operational qualification verifies that the instrument operates consistently as per its
specifications under normal condition and assures that the equipment performance is
adequate and support the process for which the equipment is intended and purchased.

 Operating the Equipment:

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

 Description of the Control Panel:-

 Digital Temperature Controller.
 Mains Switch.
 Mains indication lamp.
 Heater indication lamp.

 Standard operating procedure:

 Plug in the 3-pin top (15 amps) in a three-pin socket (15 amps) and put it on.
 Put on the mains switch on the control panel, a Red lamp will glow as stated and the
machine will start and the controller will show the room temperature.
 Press the temperature set switch on the controller, then you have to adjust the
temperature set potentiometer to set the desired temperature on the digital display.
After setting the set temperature release the set switch, the temperature display will
show the normal temperature of the working chamber. When the temp goes little below
the set temperature, the heater lamp will glow ON & when the temp goes little Above the
set temperature, the heater lamp will be OFF .
 After 2 or 3 continuous cycle the temp will be maintained within accuracy (+-0.5)
specified and the controller will show the room temperature.

Pure Enterprises, Mumbai – 400 018.

Digital Incubator Pure Enterprises

 Preventive measures Procedures:-

 Before plugging the oven check earthing is proper or not.
 After keeping the samples in the chamber close the door slowly & properly.
 After the test has been completed switch off the oven or unnecessary electricity will be
consumed.

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.

Digital Incubator Pure Enterprises
PERFORMANCE QUALIFICATION
Objective:
To determine that the equipment perform as intended by repeatedly running the
system on its intended schedules & recording all relevant information & data. Results
must demonstrate that the performance consistently meets predetermined
specifications under normal conditions 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 the Installation & Operational Qualification have been
completed and approved.

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

Room Temperature: 30oC

For temperature set above the room temperature.

Set Temperature Under shooting Over shooting Accuracy

37oC 36.6oC 37.4oC +_0.4oC
40oC 39.5oC 40.5oC +_0.5oC
50oC 49.6oC 50.5oC +_0.5oC
60oC 59.6oC 60.4oC +_0.4oC

The equipment was set at following temperatures and accuracy was +_0.5oC which is OK as
specified and satisfactory.

The Installation, Operational, Performance qualifications and the Incubator have been
examined and meet our entire requirement and it is acceptable. We certify the equipment is
Qualified for laboratory use.

Installation Engineer. Installation Checked by

Pure Enterprises, Mumbai – 400 018.

Digital Incubator Pure Enterprises

This is certify that the Digital Incubator, 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.