Leak Test Apparatus , Purpose :
Leak Test Apparatus , The purpose of this SOP (Standard Operating Procedure) is to describe the operation, calibration and cleaning of leak test apparatus.
Leak Test Apparatus , Scope :
This procedure is applicable for leak test apparatus (Model: Electrolab, LT-101P ) used in the In Process Check of General Block at XX Pharmaceuticals Limited.
Definitions / Abbreviation:
N/A
Responsibilities:
[][]The roles and responsibility is as follows:
Executive, Quality Assurance
[][]To ensure that this procedure is followed.
[][]To maintain the records properly as per SOP.
Asst. Manager, Quality Assurance
[][]To ensure that this procedure is kept up to date.
[][]To arrange training on the SOP to all concerned personnel.
[][]To ensure implementation of the SOP after training.
Manager, Quality Assurance
[][]Approval of the SOP.
Procedure:
Precaution(s):
[][]Laboratory coat must be worn while handling the instrument.
[][]Disconnect the power supply before moving or cleaning of the instrument.
[][]Prior to use, user must ensure that equipment is calibrated.
[][]Preparation of Rhodamine B Dye Solution:
[][]Prepare a 2 liters solution of Rhodamine B dye by dissolving 0.5 gm of the dye in water. Take 800 ml water in a 1000 ml beaker and make it colored by adding about 5 ml of the dye solution.
Operating Procedure:
[][]Place the sample in the desiccators which is filled with Rodamin solution to the desired level.
[][]Connect the vacuum tubing between desiccators and the Vacuum Inlet Nozzle provided on the back panel of the instrument.
[][]Switch ON the power switch, then LCD screen displays LEAK TEST APPARATUS followed by SERIAL NUMBER of the instrument and changes over to Vacuum in mm, Hg and Time.
[][]Press the SET key to change to vacuum and input required data by using UP, DOWN and SHIFT keys.
[][]To change HOLD TIME press the SET key and input required data by using UP, DOWN and SHIFT keys.
[][]To show USER ID on screen, press SET key. To setup USER ID press UP or DOWN key.
[][]To change SAMPLE ID press the SET key and input required data by using UP, DOWN and SHIFT keys.
[][]To change No. of samples press the SET key and input required data by using UP, DOWN and SHIFT keys
[][]To change BATCH NO. press the SET key and input required data by using UP, DOWN and SHIFT keys.
[][]After all the data is entered, press the ENTER key and then press the RUN key to run the program which is set for required test. Then vacuum release takes place for three seconds and the pump starts and the vacuum built up which is displayed on the LCD screen. If no vacuum builds up then press desiccator top lid for a few seconds.
[][]When vacuum release reaches zero place automatically then press the print key to get full details of the test.
[][]Leak test parameters
Type of product/Pressure/Time
[][]Tablet, Capsule, Vial/450 mm-hg/5 minutes
[][]Powder for Suspension/450 mm-hg/2 minutes
Procedure for setup time, date and serial number:
[][]Switch ON the instrument and press up arrow key until hear a buzzer sound, then shows password.
[][]Enter password.
[][]The password is four digit 8824 and press enter key.
[][]Date format is 2013 02 16 (Year Month Day) and Time format is 12:15(Hours, Minutes).
[][]Input necessary data by using up, down and right shift key, Date and time can be changed.
[][]To show Serial No. on screen press Enter key
[][]Input necessary data by using up, down and right shift key, Serial No. can be changed.
[][]When all data is entered completing then press Enter key.
[][]Switch OFF the instrument.
[][]Switch ON the instrument after few minutes and check the above recorded data and verify.
Calibration procedure:
[][]Calibrated stopwatch and start timer of leak test apparatus and stop watch simultaneously.
[][]Note the reading at intervals of 60 seconds, 180 seconds and 300 seconds respectively.
[][]Acceptance criteria: 10 seconds for each interval.
[][]Vacuum gauge calibration done by external party.
[][]Frequency of calibration: Twelve months (for timer, vacuum gauge and vacuum holding capacity).
Cleaning procedure:
[][]After completion of the testing, switch off the instrument.
[][]Cleaning of leak test apparatus by using purified water and clean outer and inner surface with the help of lint free cloth.
[][]Place the apparatus for dryness for half an hour.
[][]Change the desiccator Rodamin solution twice in a week or as per required.
Annexure:
Annexure-I: Log Book of Leak Test Apparatus.