OCCUPATIONAL EXPOSURE LEVEL (OEL) IN PHARMA
In the pharmaceutical industry, Occupational Exposure Limit (OEL) refers to the maximum acceptable concentration of a hazardous substance in workplace air for a particular material or process. This limit is crucial for ensuring worker safety by controlling exposure to potentially harmful active pharmaceutical ingredients (API’s) and other chemicals. Key points about OEL,s in pharmaceuticals include: […]
LYOPHILIZER QUALIFICATION IN PHARMA
Lyophilizer Qualification in Pharma is an important aspect in pharma. Lyophilization, also known as freeze-drying, is a process used to preserve a perishable material or make it more convenient for transport. It works by freezing the material and then reducing the surrounding pressure to allow the frozen water in the material to sublimate directly from […]
ERP VALIDATION IN PHARMA
SITE ACCEPTANCE TEST (SAT)
All criticalities emerged during the FAT exercise are then checked again at the final site, after installation and verification; additional test cases may also be added to the Site Acceptance Test (SAT) protocol to check for potential failure modes. SAT testing is performed once all connections between the new equipment and other machines/software’s are in place, under […]
API QUALIFICATIONS IN PHARMA
An “API Starting Material” is a raw material, intermediate, or an API that is used in the production of an API and that is incorporated as a significant structural fragment into the structure of the API. API Starting Materials normally have defined chemical properties and structure. API Qualifications in pharma is usually carried out by […]
DRY POWDER ORAL SUSPENSION QUALIFICATIONS IN PHARMA
Dry powders for oral suspension are powder mixtures that require the addition of water (reconstitution) at the time of dispensing and are mostly for paediatric use. These are called dry syrups or reconstitutable oral suspensions.
AEROSOLS QUALIFICATIONS IN PHARMA
Pharmaceutical Aerosols are pressurized dosage forms containing one or more active ingredients which upon activation emit a fine dispersion of liquid and/or solid materials in a gaseous medium.Aerosols are used to administer drugs to the lungs especially to treat respiratory conditions. They can also be used for topical application of drugs and for systemic action […]
FACTORY ACCEPTANCE TEST (FAT)
In the world of Pharmaceuticals, a Factory Acceptance Test (FAT) is simply a series of test for a newly manufactured equipment. With a Factory Acceptance Test, you make sure that everything works properly before you deliver an Equipment to a customer. A Factory Acceptance Test (FAT) is usually performed by quality managers, operators, design engineers, and maintenance […]
TEMPERATURE MAPPING STUDY OF COLD CHAMBERS, INCUBATORS, WAREHOUSES, TRANSPORT VALIDATION, STABILITY CHAMBERS & REFRIGERATORS FOR PHARMACEUTICAL INDUSTRY
The pharmaceutical industry places a lot of importance on the temperature mapping study of cold chambers, incubators, warehouses, transport validation, stability chambers, and refrigerators for the pharmaceutical industry. The majority of medications should be kept between 2 and 8 degrees Celsius, while those should be kept between 15 and 25 degrees Celsius. The therapeutic effects […]
