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| All sanitation activities are followed as per validation protocols. Written cleaning procedure of all the equipments and areas are available and are displayed in the respective area near the equipments. The sanitation/cleaning works are documented in respective log sheet after completion of work. |
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| Cleaning of the critical areas such as microbiology section, filling area and manufacturing area is done as per written procedure. The production equipments are cleaned as per the cleaning validation protocols. This is further checked by QC personnel as per written procedures. The major active ingredient is tested for cleaning of the equipment and released if found satisfactory. |
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| Standardisation : |
| Protocols reveal effective dilution of disinfectant, which is useful for successful control of microbial contamination in different areas. |
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| Frequency of cleaning : |
| is as per the written procedures. |
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| Changing of Cleaning Agents : |
| Changing of cleaning agents is one of the important steps in sanitation. Disinfectants and cleaning agents are changed routinely as per SOP. This is helpful to control resistant microorganisms. |
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| All the cleaning procedures are validated. |
| Evaluation of the method of effectiveness of cleaning is by |
| H Different culture concentration method. |
| H Swab Testing method |
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| Sanitation of Water Supply System |
| Importance : To control microbial contamination effectively. |
| Frequency is as per the written procedures. |
| Fumigation : is carried out as per SOP. |
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| Evalution of Microbial Contamination after fumigation : |
- Plate Exposure
- Air sampling
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| Plate Exposure : is done to identify pathogenic organisms. |
| Plate exposing is helpful in evaluating the contamination of the area and effectiveness of fumigation. For each area microbial load limit is set. |
| Recording : Every Place of Fumigation is recorded. There are specified limits and procedures for microbial count. |
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| Air Sampling : |
| Centrifugal air sampling instrument : |
| It is useful in checking the quality of air in core areas. Limits are laid and testing is performed as per SOP and recorded. |
| Microbiologist along with Plant manager is responsible for maintaining and revising of records of all microbiological activities. |
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