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This document discusses clean room classifications and microorganisms. It provides details on the typical microflora found in clean rooms, which includes skin bacteria like Staphylococcus and environmental bacteria like Bacillus. It also discusses particle counting standards for classifying clean rooms based on ISO and FED-STD-209E standards. The document then provides information about Airtech Equipment, a Singapore company that designs and manufactures customized clean room, bio-safety and operating room equipment for industries like healthcare, laboratories, and semiconductors.
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- The importance of microbiology in contamination control and why microbes are studied. It describes common types of microbes like bacteria, fungi, and viruses.
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MANUFACTURING OF PARENTRALS.pptx
MANUFACTURING OF PARENTRALS
1. Formulation and Raw Materials:
Concept: The process begins with the formulation of the parenteral drug, determining its composition and concentration.
Raw Materials: High-quality pharmaceutical-grade raw materials, including active pharmaceutical ingredients (APIs), excipients, and solvents, are selected based on their compatibility and purity.
2. Sterilization of Raw Materials:
Concept: Due to the sterile nature of parenteral products, all raw materials, including the API and excipients, must undergo rigorous sterilization.
Methods: Common sterilization methods include autoclaving, filtration, and aseptic processing to ensure aseptic conditions throughout the manufacturing process.
3. Manufacturing Process:
Preparation: The formulation is prepared, and various components are weighed and measured precisely.
Mixing: The ingredients are mixed under controlled conditions to achieve a homogeneous blend, ensuring uniform distribution of the API and other components.
Filtration: The solution is then filtered to remove any particulate matter and ensure clarity.
Filling: The sterile drug solution is filled into vials, ampoules, or other suitable containers in a controlled environment, maintaining sterility.
4. Sterilization of Final Product:
Terminal Sterilization: The final product, in its container, undergoes terminal sterilization methods like autoclaving or gamma irradiation to eliminate any microbial contamination that may have occurred during the manufacturing process.
SSV PPT
Air Care Projects provides clean room solutions as a single window service provider. They have expertise in designing, manufacturing, supplying, installing and commissioning clean rooms for industries such as pharmaceuticals, hospitals, electronics, and food. They create clean rooms of various classes from 100 to 100k. They also provide bio safety labs from BSL-1 to BSL-3 and kitchen ventilation systems. They have completed various clean room projects for customers from industries such as pharmaceuticals, healthcare and research labs.
HOW AIR STERILIZERS WORK?
Conventional and hazardous air sterilization techniques like fumigation and ozonators are inefficient in handling sterility of air, which is the most important aspect. Most of the cross-infection occur through air as all microorganisms travel through air borne particles. Fumigation technique has a very momentary effect as far as sterilization of air is concerned.
Disinfection Sterilization
Airtech is an innovative Singapore based healthcare equipment suppliers that offer all type of hospital equipments, Clean Partition Equipments, Hand washer and Dryer and Laboratory/Bio safety equipments with affordable cost and effective quality..http://www.airtech.com.sg/
M icrobiological surveillance of ots
The document discusses the history of hygiene practices in hospitals and their role in reducing infection rates. It outlines various sterilization methods used such as autoclaving and highlights the importance of monitoring effective sterilization. The document also discusses the factors that influence infection rates and the methods used for air surveillance in operating theaters, including settle plate counts and slit sampler tests.
Microbiology Laboratory Qualifications and Microbial Testing Techniques
Microbiological Lab Practices,Microbiological Lab Qualifications, Microbial Testing Procedures, Microbial Testing Techniques
Alternate ventilation in hospitals
1) Hospital ventilation systems are important to prevent the spread of diseases by controlling air quality, temperature, humidity and airflow.
2) Older conventional ventilation systems had limitations, while new mechanical systems require more space, energy and maintenance.
3) A properly designed system can clean air and create clean zones, while a poorly designed one can spread infections via airborne contaminants from various sources within the HVAC system.
General List of Activities
This document discusses Melius's expertise in cleanroom design, construction, and validation for applications in pharmaceuticals, laboratories, and other industries. Melius offers turnkey cleanroom projects from conceptual design to certification, covering a wide range of cleanroom classes from ISO 1 to ISO 9. Services include cleanroom components, separative devices, and testing to standards like ISO 14644 and USP 797. Particle counting is performed to validate cleanroom classifications.
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Hospital equipments
- 1. Hospital Equipments Services Singapore
- 2. In the healthcare and pharmaceutical sectors, control of microorganisms is important, especially microorganisms that are likely to be deposited into the air stream. Studying clean room micro flora is of importance for microbiologists and quality control personnel to assess changes. Variations in the types of micro flora may indicate deviations from the normal types such as resistant strains or problems with cleaning practices.
- 3. In assessing clean room microorganisms, the typical flora are primarily those associated with human skin (Gram-positive cocci), although microorganisms from other sources such as the environment (Gram-positive rods) and water (Gram-negative rods) are also detected, although in lower numbers. Common bacterial genera include Micrococcus, Staphylococcus, Corynebacterium, and Bacillus, and fungal genera include Aspergillums and Penicillin.
- 4. Clean rooms are classified according to the number and size of particles permitted per volume of air. Large numbers like "class 100" or "class 1000" refer to FED-STD-209E, and denote the number of particles of size 0.5 µm or larger permitted per cubic foot of air.
- 5. The standard also allows interpolation, so it is possible to describe, for example, "class 2000".A discrete-particle-counting, light-scattering instrument is used to determine the concentration of airborne particles, equal to and larger than the specified sizes, at designated sampling locations.
- 6. Small numbers refer to ISO 14644-1 standards, which specify the decimal logarithm of the number of particles 0.1 µm or larger permitted per m3 of air. So, for example, an ISO class 5 clean room has at most 105 particles/m3.Both FS 209E and ISO 14644-1 assume log-log relationships between particle size and particle concentration.
- 7. For that reason, zero particle concentration does not exist. The table locations without entries are no applicable combinations of particle sizes and cleanliness classes, and should not be read as zero. Because 1 m3 is about 35 ft3, the two standards are mostly equivalent when measuring 0.5 µm particles, although the testing standards differ. Ordinary room air is around class 1,000,000 or ISO 9.
- 8. Airtech Equipment started its operation in the year 1984, since 2000 a Singapore joint venture between Utopia –Aire Pte Ltd and Airtech Japan Ltd, was incorporated to manufacture unique and high quality Clean room, Bio-safety and Operating Room Equipment’s.
- 9. Airtech designs and Manufactures the clean room, Bio-safety and Operating Room equipment’s to customer’s requirement and also the products are be customized through professional design team for different industries. The product diversification will be able to meet the needs of different industries like Healthcare sterilize portable equipment , Hospital (PCR , Cytotoxic, Isolation, JCI, Tuberculosis (TB) Isolation mobile booth and ICU room), Laboratory & Bio safety lab (BSL1,BSL2 , BSL3, BSL4) and Semi-Conductors.
- 10. Airtech Equipment Pte Ltd Contact Us: 7 Kaki Bukit Place, Eunos Tech Park, Singapore 416185 Tel : (65) 6746-6194 Fax: (65) 6747-0327 / 6746 4994 Email : info.airtech.biz@gmail.com Web : http://www.airtech.com.sg/ To Order Find Out More Information On Hospital Solutions Please Come And Visit Us Today Onwards..!