by - OBJECTIVE:
The purpose of this document is to describe a procedure for bio-burden of primary packaging materials.
- SCOPE:
This SOP is applicable for the procedure for bio-burden of primary packaging materials.
- RESPONSIBILITY:
Microbiologist
- ACCOUNTABILITY:
QC Head
- PROCEDURE:
- Collect 10 gm sample in case of aluminium foil and PVC sheet as per SOP for sampling packing material.
- Use clean and sterilized sampling devices to avoid external contamination.
- Bring sample to microbiology lab for testing.
- Carry out test under LAF.
- For Aluminium Foil and PVC Foil: Prepare sterilized swab in saline and take aseptically swab of 5X5cmarea from the internal surface of aluminium foil and PVC sheet with the help of sterilized 5X5cm template in such a way total 5X5 cm area is to be covered properly.
- Dip swab stick in saline tube and vortex it properly and filter whole content of saline through sterilized filtration assembly (0.45μ membrane filter) and rinse membrane filter with 100 ml of sterilized 0.1% peptone water.
- Lift membrane filter with sterilized forceps and place it on pre-incubated soybean casein digest agar plate avoiding air bubble entrapped under filter paper.
- Incubate plate at 30-350C for 48 hrs for bacterial observation & then incubated at 20-250C for 72 hrs for fungal observation.
- After incubation take observation and record the result.
- Test frequency:
- Initial three consignments of every new vendor and after every three month.
- Acceptance Criteria: NMT 100 CFU/ 5X5cm area.
- TRAINING:
Trainer : Manager – Quality Control
Trainees : Staff of the microbiology departments
- DISTRIBUTION:
Master Copy : QA Department
Controlled Copy : Microbiology Department
Display Copy : Microbiology Department (If Required)
- REFERENCES:
In-House
- ABBREVIATIONS:
| Abbreviations | Extended Form |
| SOP | Standard Operating Procedure |
| NA | Not Applicable |
| MB | Microbiology |
| Sr. No. | Serial Number |
| QA | Quality Assurance |
| DEPT. | Department |
| IPA | Isopropyl Alcohol |
| % | Percentage |
