Digital Tablet Disintegration Apparatus

DIGITAL TABLET DISINTEGRATION TEST

APPARATUS

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 Tablet Disintegration Apparatus

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 Tablet Disintegration apparatus
b) Make : Pure Enterprises
c) Model No. : PE-12
e) Serial No. :
f) Date recd :
g) Date Installed :

 Specifications of Instrument
 No. of Baskets : Double Baskets (2x 6 Test)
 Stroke/Event : 50mm, approx. 30 Strokes or Events/min by motor
drive single bar up & down smoothly to lift two
baskets
 Strokes/Events Time Setting & : 4 digit minutes/seconds Timer
measured by
 Bath Size : 330L X 200W X 210H mm..
 Material : Acrylic
 Working Temperature : 37oC , +/- 1 oC
 Temp Controlled by : Digital temperature controller with PT 100 as sensor.
 Heater : Immersion heater 500Watts.
 Location : Room free from dust
 Mains Switch : 5 Amps
 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.

Digital Tablet Disintegration Apparatus

 Pre-Installment requirement
 Keep room Clean & free from dust.
 5 Amps 3 pin socket for connection.
 Voltage stabilizer required if there is power fluctuation.
 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.

Digital Tablet Disintegration Apparatus

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 Tablet Disintegration Test Apparatus to test the disintegration of which
determines whether tablets disintegrate with prescribed time when placed in the liquid
medium under the prescribed experimental conditions.

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.
 Digital Timer
 Press switch for timer reset/start/stop on timer
 Heater On/off switch.
 5 Amps mains On/off Switch.

 Standard operating procedure:

 .Checked the instrument is clean and free from dust.
 Checked that all the switches are off in normal position.
 Fill the tank bath with distilled water up to the water level mark.
 Fill the 2 nos. glass beakers of 1000ml capacity with distilled water and put them immersed
in the water bath.
 Switch on the main switch of the unit red light will glow indicating that the mains supply is
“ON”.
 Switch on the Heater switch of the unit amber light will glow indicating that the Heater is
“ON”.

Pure Enterprises, Mumbai – 400 018.

Digital Tablet Disintegration Apparatus

 Set the required temperature i.e. 37 OC on Digital temperature controller by pressing “SET”
touch switch on the Temperature Controller and wait till 37 OC temperature is displayed.
 Add the tablets in the 6 holes of the each basket along with rider hang them to the up/down
baskets holding bars and start timer by pressing Start switch.
 Both the baskets will move up & down.
 As soon as tablets disintegrate or dissolve press the stop function of press switch and note
the time in minutes/seconds on the digital timer.
 Keep all switches off when not required.

 Preventive measures Procedures:-

 Before plugging the instrument check earthing is proper or not.
 If there is power fluctuation please use voltage Stabilizer.
 Do not change set temperature parameter as it is already set by us.
 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 Tablet Disintegration Apparatus

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

Reference standard for : Liquid in Glass Thermometer, Range 0 to 50 0C , Least
calibration Count 0.1C by JRM Certificate No. V/070628001 having
traceable to NPL, New Delhi. Necessary certificate
documents enclosed herewith.

The results of comparison are as follows :

Time after Actual Temperature measured

achieving Temperature by Error
O 0
Set Temperature at C Ref. Thermometer in C
37.0 OC On Digital 0
C
Display.
10.0 a.m. 37.0 37.0 + 0.0
11.0 a.m. 37.0 37.0 + 0.0
12.0 a.m. 37.0 37.0 + 0.0
01.0 p.m. 37.0 37.0 + 0.0
02.0 p.m. 37.0 37.0 + 0.0

The equipment was set at following temperatures and accuracy was +_1oC which is OK as
specified and satisfactory.

The Installation, Operational, Performance qualifications and disintegration apparatus for

suppository 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 Tablet Disintegration Apparatus

This is certify that the Digital Tablet Disintegration Apparatus 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.