1. OBJECTIVE
To lay down a procedure for qualification of visual inspectors for media fill vial inspection.
2. RESPONSIBILITY
2.1 Technical Assistant – To undergo the qualification test.
2.2 Microbiologist – Preparation of vials / check for qualification.
3. PROCEDURE
3.1 Materials and Equipment Required
3.1.1 Sterile Vials
3.1.2 Rubber stoppers
3.1.3 Flip off seals
3.1.4 S.S Tray
3.1.5 Sealer
3.1.6 De-sealer
3.1.7 Gloves & Nose masks.
3.2 Media and Culture requirement
- Sterile SCDM
- Culture suspension – Less than 100 cfu/ml of E.coli and Staphylococcus aureus
3.3 Aseptically dispense the sterile SCDM into 150 no’s of vials and seal the vials using sterile rubber stoppers and flip off seals.
Note: The quantity of media dispensed should not be less than 50 % of the vial size.
3.4 Likewise dispense sterile SCDM in another 30 no’s of vials under the biological safety cabinet.
3.5 Make the prepared SCDM vials into two sets containing 15 nos. of vials for each set.
3.6 Set -1 vials shall be inoculated with 3 different inoculum size of E.coli (i.e., 0.25 ml, 0.5 ml, and 1.0 ml culture suspension) in each of 5 no’s of sterile SCDM vials.
3.7 Set -2 vials shall be inoculated with 3 different inoculum size of Staph. aureus (i.e., 0.25 ml, 0.5 ml,and 1.0 ml culture suspension) in each of 5 no’s of sterile SCDM vials
3.8 Seal both the Set-1 and Set-2 vials.
3.9 Incubate all the culture inoculated SCDM (30no’s) and sterile SCDM (150 no’s) vials at 30-35°C for 24- 48 hours. After the incubation period check the inoculated vials for turbidity and proceed for visual inspection test.
3.10 Qualification of the inspectors.
3.10.1 The inspector shall be given a set of 150 no’s of sterile media fill vials along with 30 no’s of turbid vials that are numbered serially from 1, 2, 3,.. up to 180, mixed and kept randomly in a S.S tray.
3.10.2 The vial inspection for turbidity shall be done in the black/white background under fluorescent light.
3.10.3 After completion of visual inspection, the inspector shall separate all the turbid vials from sterile vials and the same shall be verified by the microbiologist.
3.10.4 The details of turbid vials and sterile vials shall be entered in Annexure1.
3.10.5 Based on the assignment of the vials i.e. 100%, the inspector shall be qualified. If the visual inspector fails to separate all the turbid vials repeat the qualification test.
3.10.6 Re-qualification of the inspector shall be carried out once in a year.
3.10.7 Eye check of the inspector shall be carried out once in six months
4. ABBREVIATIONS
4.1 QA – Quality Assurance
4.2 QC – Quality Control
4.3 Cfu – Colony forming units
4.4 SCDM – Soya bean casein digest medium
4.5 no’s – Numbers
5. REFERENCES
Nil
6. ANNEXURES
6.1 Annexure-1 Vial inspection Qualification Record
Annexure-1
VIAL INSPECTION QUALIFICATION RECORD
Name of the inspector :
Date of qualification test:
Type of vials:
| S.No | No .of Sterile vials observed | No .of Turbid vials observed | Qualified | Disqualified | Total |
| Done by/Date | |||||
| Checked by/Date |
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