QAS-024 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 378

SOP No. QAS-024.00 Effective date: mm/dd/yyyy
Approved by:

Subject: Fill Volume, Color, and Particulate Matter in Drops Bottles

43.1 PurPose
This SOP outlines the stepwise procedure to check and confirm the fill volume, color, and particu-
late matter in drops bottles.

43.2 resPonsibility
The area QAI and the QA officer will be responsible for ensuring correct fill checks, color, and
checks for particulate matter of the product and other related checks. The QA manager is responsi-
ble for system compliance.

Equipment Required

1. Volume checks

a. 400 mL beakers

b. Acetone

c. Deionized water

d. Six 25 mL calibrated cylinders

e. Six 50 mL calibrated cylinders

2. Particulate matter/color check

a. Optical checking hood

Frequency

Every hour of filling of drops.

43.3 Procedure
After line clearance granted by the packaging supervisor, the QAI/QA officer will check and con-
firm the following steps during the first round in the area to confirm the line clearance.

1. The area and equipment are to be kept clean.

2. Commodities mentioned in the master packaging instructions requisition tallies and no
other commodity should lie in the area except the ones mentioned in the requisition.

3. Filtration set up, gas connections (where required) and their flow is satisfactory.

4. Operators and workers in the area are properly dressed and wear masks, gloves, and gog-
gles, if necessary, taking all precautionary measures.

5. Equipment and area sanitization/cleaning record is satisfactory.

When all the above requirements are found satisfactory then sign on the line clearance form.

43.3.1 f ill v olume c heck

1. Check the volume by emptying the contents (depends upon number of nozzles) directly
into a calibrated cylinder.

2. If the average volume and range crosses the in-process limits, then ask the concerned to
adjust the machine and inform the packaging supervisor.