Follow
1.0 OBJECTIVE : To set up a general and practical approach on safe microbiological practices for all persons involved with microbiological quality control.
2.0 SCOPE : This SOP is applicable for all persons involved with the microbiological exercise in the laboratory.
3.0 RESPONSIBILITY
3.1 All personnel involved in the microbiology laboratory.
3.2 Overall responsibility for training, implementation & follow-up with the QC Manager or his nominee.
4.0 ACCOUNTABILITY
4.1 Head of Quality.
5.0 PRECAUTIONS
5.1 Keep fingers, pencils, bacteriological loops etc. out of mouth.
5.2 Do not drink from laboratory glassware.
6.0 PROCEDURE
6.1 Prerequisite for safe practices
6.1.1 Effective disinfectant should be available for immediate use in the event of a spillage.
6.1.2 The laboratory should be easy to clean. Bench surface should be impervious to water and resistant to acid, alkali, solvent and disinfectant.
6.1.3 A comfortable working environment is an important safety consideration, since stress arising from conditions which are too hot or too cold is more likely to lead to an accident.
6.1.4 Sufficient lighting should be provided in the laboratory because poor lighting and shadow contribute to the deterioration in safe working practices.
6.2 General safe practices
6.2.1 Avoid eating, drinking, smoking and application of cosmetics in the laboratory. Mouth pipetting is also a significant hazard and is strictly prohibited.
6.2.2 All employees and visitors in microbiological laboratories shall wear laboratory clothing and laboratory shoes or shoe covers. Laboratory clothing including shoes shall not be worn outside the work area.
6.2.3 Hand gloves and mask should be used while conducting analysis.
6.2.4 All the analysis must be carried out under the laminar air flow workstation to prevent unwanted contamination.
6.2.5 Before and after analysis clean the laminar air flow workstation with 70 % IPA.
6.2.6 After analysis clean the laminar air flow workstation with SPOR KLENZ when work with spore former microorganisms.
6.3 Handling of microbial standard culture
6.3.1 All microorganisms vary in their ability to cause infection in human. Microorganisms used in pharmaceutical quality control procedures range from organisms not associated with human disease to those which have significant pathogenic potential. So, these organisms can be assumed as potential biohazard substances.
6.3.2 During the analysis avoid direct contact with organisms.
6.3.3 Minimize aerosol generation and use mask when working in front of laminar air flow.
6.3.4 After handling of standard culture, clean the working area with disinfectant solution.
6.4 Handling of contaminated media, equipments and biohazard substances
6.4.1 All the used and contaminated plate, media, glass ware and utensils must be discarded and washed after decontaminated by autoclaving.
6.4.2 Hand should be decontaminated immediately when contamination is suspected and before leaving the laboratory.
6.4.3 Contaminated materials whether for reuse or disposal should be stored and transported in robust and leak proof containers without spillage.
6.4.4 Accidents and incidents should be immediately reported to the supervisor and recorded.
