Differences between Sanitization and Sterilization? How to clean the Product Manufacturing Vessels?
1.How to sanitize the Water Supply lines?
Sanitize the water supply lines
Sanitize by Steam flush and Chlorinization.
2.How to clean the Product Manufacturing Vessels?
Wash the vat with portable water. Rubbing the vat & lid with 1% sodium lauryl sulphate & then washing the inner side & outside with potable water. Washing the vat by hot water & then rinsing the vat with DM water. Rubbing the vat with 70% IPA. And the cleaning procedure must be validated.
3.What are the differences between Sanitization and Sterilization?
Sterilization
Sterilization is a process or technique to remove bacteria and all types of viable microorganism.
Duration: 14 days
Sanitization
Reduction the number of micro-organism to a safe or relatively safe level as determined by applicable, regulations or the purpose of application
Clean Room & Aseptic Area, Air lock & Site Master File
1.What is Clean Room & Aseptic Area?
Clean Room
A room in which the concentration of airborne particles is controlled to meet specified airborne particulate cleanliness class. In addition, the concentration of microorganisms in the environment is monitored; is cleanliness class defined is also assigned a microbial level for air, surface, and personnel gear.
Aseptic Area
Any area in an aseptic process system for which airborne particulate and microorganism levels are controlled to specific levels appropriate to the activities conducted within that environment.
2.What is Air lock?
Airlock: An enclosed space with two or more doors, which is interposed between two or more rooms, e.g. of differing classes of cleanliness, for the purpose of controlling the airflow between those rooms when they need to be entered. An airlock is designed for use either by people or for goods and/or equipment.
3.What Is Site Master File ?
Site Master File
Site Master File is prepared by the manufacturer and contains specific information about the quality assurance, the production and/ or quality control of pharmaceuticals manufacturing operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings. If only part of a pharmaceuticals operation is carried out on the site. A site master file need only describe those operations that is analysis packaging etc.
Sterilization, HVAC, Autoclave & DHS
1.What is sterilization? Mention the duration sterility test.
Sterilization is a process or technique to remove bacteria and all types of viable microorganism.
Duration: 14 days
2. Write the types of Sterilization.
Type of Sterilization:
Terminal Sterilization
1) Steam Heat sterilization
2) Dry Heat sterilization
Others sterilization
3) Gas sterilization
4) Sterilization by ionizing Radiation
5) Sterilizing by Filtration
6) Aseptic Processing
3.Write the functions & use of HVAC system.
Functions and use of HVAC
Heating, Ventilating and Air conditioning system is used for temperature and humidity control with in a manufacturing environment. It includes air handling units, air distribution network, air-cooling and heating system, air filtration, equipment control system, monitoring and alarm decreases
4.Write the conditions of sterilization by Autoclave & DHS.
Condition of sterilization by Autoclave & DHS
121 0 C 15 lbs pressure per square inch 15 minutes
200 o C for 1 Hour.
21. What are the points to be checked during validation of DHS/ Autoclave?
Points to be checked during validation of DHS/Autoclave
Checked by biological indicator (Bacillus sublitis) and endotoxin indicator for DHS
Checked by biological indicator (Bacillus stearothermophilus).
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