Material safety data sheet (MSDS)

What is a Material Safety Data Sheet, commonly referred to as MSDS? A material safety data sheet (MSDS) is a documented resource that supplies users and emergency responders with essential information and procedures for the safe handling and use of chemicals. MSDSs have existed in various forms since the era of the ancient Egyptians. While … Read more

BASIC UNDERSTANDING OF pH METER

A pH meter is an electronic device used for measuring the pH (acidity or alkalinity) of a liquid (though special probes are sometimes used to measure the pH of semi-solid substances). A typical pH meter consists of a special measuring probe (a glass electrode) connected to an electronic meter that measures and displays the pH … Read more

HANDLING OF ALTERNATE VENDOR DEVELOPMENT (AVD) PROJECTS:

Alternate Vendor development for existing material shall be initiated through the Change control procedure. Supply chain / purchase team on its own or on the recommendation of Technology Transfer team / R&D / Production shall identify the vendor for existing material. Supply Chaim (SCM) / purchase Team shall initiate queries with the prospective vendors for … Read more

UNDERSTANDING ON WORKING PRINCIPLE OF RAPID MIXER GRANULATOR (RMG):

Homogenous mixing of dry & wet powders, de-agglomeration / de-lumping of wet mass and fast dispersion of binding agent. Dust free, high free flowing dosing particles, high uniformity of granule size. AC frequency control for bottom driven Impeller Mixer with 3 or 4 blades with exclusive scrape side design and Chopper positioned to make granules. … Read more

UNDERSTANDING ON WORKING PRINCIPLE OF FLUID BED DRYER (FBD):

Fluid Bed Dryers (FBD) are primarily used in almost all chemical, pharmaceutical, food, dyestuff and other process industries to dry materials by fluidization with hot and / or dehumidified air, which creates a turbulence in the wet product (not totally liquid) while flowing through it. WORKING PRINCIPLE: The atmospheric air is sucked in the dryer … Read more

UNDERSTANDING ON WORKING PRINCIPLES OF SIFTER (VIBRATORY SIFTER):

VIBRO SIFTER, VIBRO SCREEN: Vibro separators are circular gyratory screens used to separate solids from solids and liquid from solid. Vibro Sifter consists of Specially Designed Motor mounted vertically at the center of the base plate of the Screen. The Screen is in between feeding hopper and bowl. The material is fed on to the … Read more

BASIC UNDERSTANDING OF DIFFERENT EQUIPMENT AND CRTICAL OPERATING PARAMETRS:

Equipment must be located, designed, constructed, adapted, and maintained to suit the operations to be carried out. The layout and design of equipment must aim to minimize the risk of errors and permit effective cleaning and maintenance in order to avoid cross-contamination, build-up of dust or dirt, and, in general, any adverse effect on the … Read more

BASIC UNDERSTANDING OF QUALIFICATION, CALIBRATION AND PREVENTIVE MAINTENANCE:

QUALIFICATION: Qualification is the planning, carrying out and recording of tests on equipment and systems, which form part of the validated process, to demonstrate that it will perform as intended. All manufacturing equipment, laboratory instrument and supporting utilities shall be considered for qualification. After successful completion of qualification exercise, the Equipment / instrument / Utilities … Read more

BASIC UNDERSTANDING OF AREA AND ROOM CONDITIONS:

The premises used for warehousing, manufacturing, processing, storage, packaging labeling and testing purposes shall be; WAREHOUSING AREA: PRODUCTION AREA: ANCILLARY AREAS: QUALITY CONTROL AREA: REFERENCE: 1. Schedule M 2. 21 CFR art 210 & 211 3. WHO Technical Report Series 908

COATING PROCESS IN PHARMACEUTICAL MANUFACTURING:

UNDERSTANDING COATING: Coating can be defined as a physical deposition of a layer on Tablet surface for the purpose of masking the Taste, odour, appearance, physical / chemical protection or to control the drug release. Coating process is the application of coating composition to a moving bed of Tablets in a coating pan by concurrent … Read more