Company Name:: Version No.
Humanwell Pharmaceutical Ethiopia PLC 1
Title:
Document No:
Fill Volume/Weight and Other Checks for Parenteral Page No.
SOP/SL/004 Page 1 of 4
Products during Filling
Effective Date Revision Date
Fill Volume/Weight and Other Checks for Parenteral
Products during Filling
Prepared by： X X
Department Name Date
Approved by： Y Y
Department Name Date
Authorized by： Z Z
Department Name Date
Company Name:: Version No.
Humanwell Pharmaceutical Ethiopia PLC 1
Title:
Document No:
Fill Volume/Weight and Other Checks for Parenteral Page No.
SOP/SL/004 Page 2 of 4
Products during Filling
Effective Date Revision Date
1. Purpose
The purpose is to provide a procedure for the fill check (by weight and/or by volume) for
liquid products (ampoules/vials) and for powder by weight and prefilled syringes
2. Scope
This procedure is applicable to all Small Volume Parental Products Fill weight control in the
injectable manufacturing plant in Humanwell Pharmaceutical Ethiopia PLC
3. Validity
This SOP is valid only until next revision date and if it bears control seal.
4. Responsibility
It is the responsibility of the area QA inspector to carry out the testing per the described
procedure. The quality assurance (QA) manager will be responsible for SOP compliance.
5. Material and Equipment
a. One syringe each of 2, 5, and 10 ml fitted with 21-gauge needle of NMT 1 in. in length
b. 400ml beakers
c. Ethanol
d. WFI
e. Only 10-ml cylinder
f. Balance
6. Procedure
6.1. Fill volume check for liquid
6.1.1. Take eight samples from the machine.
6.1.2. Place a dry cylinder on calibrated balance and tarePlace a syringe in the cylinder and
tare.
6.1.3. Remove the syringe from the cylinder.
Company Name:: Version No.
Humanwell Pharmaceutical Ethiopia PLC 1
Title:
Document No:
Fill Volume/Weight and Other Checks for Parenteral Page No.
SOP/SL/004 Page 3 of 4
Products during Filling
Effective Date Revision Date
6.1.4. Take up the content of first containers in the dry hypodermic syringe of a rated
capacity not exceeding three times the volumes to be measured.
6.1.5. Expel any air bubbles from the syringes and needle.
6.1.6. Then place the filled syringe back on the cylinder.
6.1.7. Note the weight in grams on the control chart.
6.1.8. Repeat the same procedure for the remaining seven ampoules.
6.1.9. Take out the average of the eight ampoules or vials or prefilled syringes (by weight)
and write in the average column.
6.1.10. Find out the range by subtracting the lowest weight from highest weight (eight
ampoules checked) and note in the range column.
6.1.11. Plot the average and range for each hourly check.
6.1.12. Each hour, also check on three ampoules the length of the ampoules, sealing,
particles, break ring presence, or any printing and note down in X and R charts for
parenterals.
6.1.13. Immediately inform the supervisor in case of any adjustment required for volume or
any physical defects.
6.1.14. Control limits for the average chart will be drawn on the basis of specific gravity
done by QC at the time of bulk sample analysis prior to filling.
Exceptions
For volumes of 10 ml or more, the content of containers (ampoules) holding more than 10 ml
will be directly transfer
Excess volume
Labeled Size Mobile Liquids Actual
(ml) (ml) Theoretical (–1%)
1.0 0.10 ml 1.1 ml 1.09 ml
Company Name:: Version No.
Humanwell Pharmaceutical Ethiopia PLC 1
Title:
Document No:
Fill Volume/Weight and Other Checks for Parenteral Page No.
SOP/SL/004 Page 4 of 4
Products during Filling
Effective Date Revision Date
2.0 0.15 ml 2.15 ml 2.12 ml
3.0 0.2 ml 3.15 ml 3.12 ml
4.0 0.3 ml 4.3 ml 4.25 ml
5.0 0.3 ml 5.3 ml 5.25 ml
10.0 0.5 ml 10.5 ml 10.40 ml
20.0 0.6 ml
7. Abbreviations
SOP - Standard Operating Procedure
8. Related Documents /Applicable document/
None
9. Revision History
Versio
Revision Description
n No.
1 New
