1.0 OBJECTIVE : To lay down a procedure for sampling and testing of packing materials.
2.0 RESPONSIBILTY
Microbiologist / Q.C Executive
3.0 ACCOUNTABILITY
Quality Control Manager
4.0 PROCEDURE
4.1 Collect the intact packs of Bottles / ROPP caps / Inner caps or any other primary packing materials (Annexure-1) from the consignment and transfer to Microbiology laboratory. Carry out sampling under laminar air flow in MLT area. Seal the containers properly and send it back to warehouse.
4.2 Prepare 3x100ml of 0.9% of NaCl solution and sterilize by autoclaving ,for sample of each consignment of packaging material (for small items like caps ,rubber stoppers used for oral packaging material etc) .
4.3 Open the sample under LAF and submerge 20units in the prepared solution and swirl it for 10 min.
4.4 Transfer the solution in sterile filtration unit & filter the solution with 0.45mm filter membrane of 100ml each.
4.5 Then transfer the filter membrane in sterile SCD agar plate and incubate at 35°C for 72 hrs ,for bacteria,
SDA agar plate, for fungi, and incubate at 20-25°C for 120 hrs and note the observations, for pathogens submerge the filter membrane in 100ml of sterile SCD Medium and proceed for the testing of pathogens as per SOP
Formula : No. of cfu in each unit=Number of cfu observed on filter membrane / 6 (unit)
Limit: Bacteria NMT 5 cfu / unit, Fungi NMT 1 cfu / unit and pathogens nil / unit.
4.6 For vials and bottles used for oral packaging material pour 5 ml of sterile solution into each of the 15 containers with the help of sterile pipette and thoroughly wet the inner walls and filter the solution in sterile 0.45mm filter membrane.
4.7 Then pour rinsed solution from 5 vials in each three sterile 0.45mm membrane filter assembly and filter the solution.
4.8 Then transfer the filter membrane in sterile SCD agar plate and incubate at 35°C for 72 hrs , (for total bacterial count), SDA agar plate, (for total fungal count) , and incubate at 20-25°C for 72 hrs and note the observations ,for pathogens submerge the filter membrane in 100ml of sterile SCD Medium and proceed for the testing of pathogens as per G.P No.-
Formula : No. of cfu in each unit =Number of cfu observed on filter membrane / 5 (unit)
4.9 For pathogen testing test for S aureus , Pseudomonas , E. coli and Salmonella as per SOP No. K/QC/059.
4.10 Limit (for oral packing materials: for bottles or vials): For bacteria: 100 cfu / unit , For fungi: 10 cfu / unit., pathogens: Nil / unit
4.11 Limit (for injectable packing materials, Like vials, rubber-stoppers etc ): For bacteria.
NMT 10 cfu / unit , For fungi. <1 cfu / unit , pathogens: Nil / unit
4.11 Foils( Aluminum, PVC / PVDC Films)- Cut (three replicates) inner 20 x 20 cm with sterile tools and use contact plate (RODAC plate) for sampling
Formula :No. of cfu in 100cm2 =Sum of the number of cfu observed on three RODAC plates/ 3x 19
Limit: 50 cfu / 100cm2 (for bacteria).
5 cfu / 100cm2 (for fungi). And nil pathogen.
4.12 Note the observations in the format given in annexure-II.
5.0 ABBREVIATIONS :
cfu – Colony forming unit
°C – Degree centigrade
6.0 ANNEXURES : Annexure – Iand II
ANNEXURE – 1
Rubber plugs, Caps – 20 Nos.
Up to 20ml Bottle- 15 Nos.
30 , 50 , 60 & 100 ml Bottle – 12 Nos.
125 ml Bottle – 9 Nos.
170 , 250 , 375 ml Bottle – 6 Nos.
Vials – 20 Nos.
Frequency of testing – For every export batches OR as per requirement.
ANNEXURE –II
FORMAT FOR TESTING OF PACKAGING MATERIALS
| SAMPLE | | CONSIGNMENT No./DATE | |
| SAMPLE TY./AREA | | SAMPLED BY | |
MEDIA PREPERATIONS:
| MEDIA NAME | MEDIA BATCH NO. | STERILI. CYCLE MEDIA LOT NO. | PREPARED ON |
| 0.1%Buffered NaCl- soln. | | | |
| Soyabean Casein Digest Agar | | | |
| Sabouraud Dextrose Agar | | | |
Medium used for submerging the sample: 0.9%Buffered NaCl- solution.
TOTAL AEROBIC MICROBIAL COUNT:
LIMIT : Bacteria: Cfu per Bottle Fung Cfu per Bottle
TEST MEDIUM PLATES: For Bacteria For Fungi
No. of plates used : 1 1
Medium used : SCDA SDA
Observation Of Microbial Count
| Days ¯ | SCDA( for bacteria at 30-35°C) | SDA( for fungi at 20-25°C) | ||||
| Dil. ® | +ve control | -ve control | Cfu / plate | +ve control | -ve control | Cfu / plate |
| Ist day | | | | | | |
| 2nd day | | | | | | |
| 3rd day | | | | | | |
| 4th day | | | | | | |
| 5th day | | | | | | |
| | | |||||
Calculation:
(B) TEST FOR PATHOGEN
MEDIA PREPERATIONS:
| MEDIA NAME | MEDIA BATCH NO. | STERILIZATION CYCLE MEDIA LOT NO. | PREPARED ON |
| Cetrimide broth Media | | | |
| Mac koncy broth | | | |
| Tetrathionate broth | | Preparation of media by boiling | |
| MEDIA NAME | MEDIA B. NO. | STERILIZATION CYCLE MEDIA LOT NO. | PREPARED ON |
| Cetrimide agar | | | |
| Brilliant Green Agar | | | |
| Xylose Lysine Deoxy. agar | | | |
| Mac koncy Agar | | | |
LIMIT – Must be absent
| Organism to be tested | Primary test | Secondary test | Inference |
| S.aureus | | | |
| Pseudomonas | | | |
| E. coli | | | |
| Salmonella | | | |
TBC= cfu/unit , TFC= cfu/unit , Pathogens =
INFERENCE: The above sample complies / does not complies the test.
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