SOP For Operation and Calibration of Dissolution Test Apparatus (TDT- 08L)

This document details the procedure for the operation and calibration of the Dissolution Test Apparatus (offline sampling).

It is the policy of XYZ Limited that the written procedure shall be followed for the operation and calibration of the Dissolution Test Apparatus to ensure smooth operation and its use monitored to obtain consistent and reproducible results and to minimize downtime, in compliance with regulatory requirements.

This procedure is to be applied at the time of operation and calibration of the Dissolution test apparatus (offline sampling).

4.0 RESPONSIBILITY 

Persons along with their responsibilities and accountability are given below:

Executive - Corporate Quality Assurance:- To Prepare the SOP.

Trainee Analyst/ Jr. Analyst/ Analyst/ Sr. Analyst:- To follow the SOP accordingly

 Manager  - Corporate Quality Assurance:- To ensure implementation of SOP.

5.0 DISSOLUTION TESTER CONSISTS OF:

5.0.1 Basic instrument

5.0.2 Water bath with temperature controller

5.0.3 Set of glass/merlon jars (8 nos.)

5.0.4 Set of basket assembly (6 nos.)

5.0.5 Set of paddle assembly (6 nos.)

5.1 GENERAL INSTRUCTIONS

 Check and ensure that:

5.1.1 The instrument is clean and free from dust. If not, then clean the instrument using a lint-free duster.

5.1.2 The instrument is connected to 230 volts stabilized current (UPS).

5.1.3 The purified water in the bath is clear and up to the mark.

5.1.4 The level of the instrument using a level meter.

5.2 PRECAUTIONS

5.2.1 Replace the water in the water bath once in 8 days or whenever it is found to be turbid and clean the water bath before adding the freshwater.

5.2.2 Preferably add Cetylpyridinium Chloride in a bath of water to get 0.01% concentration after adding fresh purified water or any other suitable antimicrobial agent.

5.2.3 Disconnect the power supply while cleaning the water bath.

5.2.4 Do not pull or force the paddle or basket.

5.2.5 Do not stop the stirrer while in operation. 

Do not push the shafts forcefully.

5.2.7 Check the integrity of basket mesh prior to use.

5.2.8 Baskets & paddles must be certified for any damage prior to use. Deformed baskets or dented paddles must be taken out of use & discarded.

5.2.9 Connect the mains with proper earth points.

5.2.10 Oil the lifting arrangement regularly for smooth operation.

5.2.11 Check the lids of the jars are not kept on the jars while lowering the paddle or basket assembly.

5.2.12 After completion of the work remove and clean the jars, paddles, and baskets and keep them at their designated place.

5.2.13 Always lower the shaft assembly to the lowest position, at the end of the day and when not in use.

5.2.14 Switch ‘OFF’ the instrument after use.

5.3 CLEANING

5.3.1 Disconnect the Instrument from the main power supply.

5.3.2 Clean the instrument externally with a clean dry cloth daily.

5.3.3 Clean the dissolution vessels after every dissolution test.

5.3.4 Remove the water from the tank weekly and clean it with a wet cloth soaked in hot water. After cleaning of tank fill the tank with water. Also, clean externally with a wet cloth.

5.4 OPERATION

Connect the whole system with the main power supply & switch it on.

Switch on the power switch provided on the rear side of the panel board.

Switch on the power switch provided on the front panel of the fraction collector (FC-12).

Switch on the power switch provided on the front panel of the temperature controller.

Now, Switch on the Power switch provided on the rear side of TDT–08L. The instrument shall initialize by displaying a power flash screen, which shall flash once as for a moment:

Download:- Full SOP