sop for calibration of vessels with dipstick
1.0 OBJECTIVE:
1.1 To lay down a Procedure for calibration of vessels with dipstick.
2.0 SCOPE:
2.1 This SOP is applicable to calibration of vessels with dipstick in Injection Parenteral Departments
3.0 RESPONSIBILITY:
3.1 Officer /Executive Production
3.2 Officer /Executive QA
4.0 ACCOUNTABILITY:
4.1 Head Production
5.0 PROCEDURE:
5.1 CALIBRATION PROCEDURE FOR SS BUCKET:
5.1.1 Use the pre calibrated and certified measuring cylinder for calibration.
5.1.2 Ensure the cleanness and dryness of measuring cylinder before calibration.
5.1.3 Before weighing ensure that the balance is calibrated.
5.1.4 Keep the empty SS bucket on balance and record the weight of SS bucket add the required volume of water to SS bucket by pre calibrated measuring cylinder upto the desired mark.
5.1.5 Record the weight of filled SS bucket in Kg.
5.1.6 Determine the weight of water in kg.
5.1.7 CALCULATE:
The weight of water as follows:
C=B-A
Where,
C=Weight of water in kg
B=Weight of SS bucket with water in Kg.
A=Weight of SS bucket in Kg.
5.1.8 CALCULATE
The volume of water for SS buckets as follows:
Volume of water in ml = Weight of water in Kg/0.99602gms.
Where 0.99602gms = weight of 1mL of water at 25˚C.
5.1.9 Record the observation and recommendation in Annexure-I.
5.1.10 Frequency of calibration: once in a year.
5.2 PROCEDURE FOR CALIBRATION OF VESSELS WITH DIPSTICK:</strong
5.2.1 Ensure that vessel to be calibrated is empty, clean and dry.
5.2.2 Ensure that dipstick and vessel being used are calibrated.
5.2.3 Ensure dipstick is clean before use.
5.2.4 Ensure that the stirrer is OFF while measuring volume in the vessel.
5.2.5 Select and decide marked points on the manhole of vessel for calibration for entire range of capacity of vessel.
5.2.6 Place the dipstick at the marked position of the vessel in such a way that zero end of the dipstick
just touches the upper level of liquid/water.
5.2.7 Add the required quantity of water at room temperature with the help of previously calibrated S.S bucket.
5.2.8 Measure the height from liquid level to the marked position of the vessel on dipstick in centimeters.
5.2.9 Check the quantity of water with respect to required volume in the vessel and put the calibrated dipstick
touching to the upper layer of water and note the dipstick reading with reference to upper portion of neck
of vessel i.e dry height of dipstick inside the vessel.
5.2.10 Note the reading at selected premarked points for the entire range of capacity of vessel by filling
the report with measured quantity of water w.r.t. calibrated dipstick by repeating step 5.2.7, 5.2.8 and 5.2.9.
5.2.11 Record the observation in Annexure-II.
NOTE:
(i) Calibration should be done by user with QA.
(ii) Frequency of calibration once in a year.
6.0 ABBREVIATIONS:
Sr.No. | Abbreviation used | Full form of abbreviation used |
1. | SOP | Standard Operation Procedure |
2. | Cm | Centimeter |
3. | No. | Number |
4. | QA | Quality Assurance |
5. | w.r.t | with respect to |
6. | % | percentage |
7.0 ATTACHMENTS (ANNEXES) :
Annex-I: Calibration Record of S.S Bucket
Annex-II: Dipstick Calibration Record
8.0 REFERENCES:
In-House
Annexure-I
CALIBRATION RECORD OF S.S BUCKET
Equipment: Make:
Date of Calibration: Next Calibration due on:
Balance Code No. : Area
Weight /mL of water at 25˚C: 0.99602gms
Sr.No. | Volume of water to be calibrated
(‘X’mL) |
Weight of water to be calibrated
(Y=X×0.99602gm) |
Weight of Empty SS bucket
(‘A’ Kg) |
B=weight of SS Bucket + water
(‘B’Kg) |
Weight of water observed C=B-A Kg | Volume of observed
(D=C/0.99602 lts) |
Remarks |
Annexure-II.
DIPSTICK CALIBRATION RECORD
Equipment Name: Equipment ID:
Capacity: Make:
Dipstick ID: Calibration done on:
Area: Calibration due on:
Sr.No. | Dry Height In (CM) | Volume In Liter | Remarks |
Online Rejection in parenteral
Receipt of Batch from Production to Packing Department
sop for for Spillage Handling in parenteral area
sop for calibration of vessels with dipstick
sop for Cleaning of Bins and Containers
cip of mixing vessel and holding vessel
sop for Cleaning of Ampoule Filling and Sealing Machine
sop for Fogging in Sterile and Non Sterile Area
sop for for Filtration of Bulk Solution
sop for fumigation in production area
sop for post cleaning after media fill
sop for cip of mixing vessel mixing mobile vessel and holding vessel
sop for De-Bagging of Three Piece Vial Dropper Caps
sop for calibration and verification of check weigher
sop for Batch number and Manufacturing and Expiry Date Coding System
standard operating procedure machine history file
sop for operation and cleaning of Hand coder
sop for Cleaning and Handling and Silicone Tubes
sop on operation and cleaning of coating pan
sop for Operation of cleaning of pipe lines
sop for operation of capsule loading machine semi automatic
sop for Machine operation capsule inspection and polishing machine
Sop batch demarcation and batch coding
sop for monitoring of reprocessing of products
sop for in-process control on liquids orals
sop for in process controls on tablets capsules packaging line
sop for Issuance retrieval and destruction of BMR and analytical records
sop for in process controls during granulation compression coating inspection
sop for Cleaning of Blister packing machine
sop for for charge hand over between the shifts
Performance requalification report of visual inspectors
sop for Cleaning and operation of ROPP caps inspection table
sop for usage and destruction of filter pad and cartridge filter
sop for cleaning and storage of transfer pipe
sop for Cleaning and operation of labeling machine
Cleaning and operation of the mono block filling and sealing machine
sop for Cleaning and operation of empty bottle inspection table
sop for Cleaning and operation of filter press
sop for cleaning and operation of liquid transfer pump and line
sop for cleaning and operation of storage vessels
sop for cleaning and operation of sugar syrup manufacturing vessel
sop for cleaning issuance and retrieval of accessories and change parts
sop for Cleaning and operation of visual inspection conveyor belt
sop for Cleaning and operation of spray gun and assemble
sop for Fogging in Aseptic and Non Aseptic Area