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Capping: ‘Capping’ is the term used, when the upper or lower segment of the tablet separates horizontally, either partially or completely from the main body of a tablet and comes off as a cap, during ejection from the tablet press, or during subsequent handling.
Lamination / Laminating: ‘Lamination’ is the separation of a tablet into two or more distinct horizontal layers.
Sticking/filming: ‘Sticking’ refers to the tablet material adhering to the die wall. Filming is a slow form of sticking and is largely due to excess moisture in the granulation.
Cracking: Small fine cracks observed on the upper and lower center surface of the tablets, or very rarely on the side wall are referred to as cracks.
Chipping: ‘Chipping’ is defined as the breaking of tablet edges, while the tablet leaves the press or during subsequent handling and coating operation.
Mottling: ‘Mottling’ is the term used to describe an unequal distribution of color on a tablet.
Double Impression: ‘Double impression’ involves only those punches, which have a monogram or other engraving on them.
15 - 250 C & 35 -55% RH
In tablet manufacturing facilities, pressure gradients are maintained to avoid cross contamination of products through air. Usually processing areas are maintained under positive pressure with respect to service corridors.
In an elixir, the active ingredients are mixed with a liquid, usually a kind of syrup or alcohol, in which they can dissolve.
In a suspension, the medicine is mixed with a liquid, usually water, in which it cannot dissolve and therefore remains intact in the form of small particles. The important thing to remember is that you have to shake a suspension before giving each dose so that the medicine particles are evenly distributed throughout the liquid.
Design Qualification (DQ): documented verification that the proposed design of the facilities, equipment, or systems is suitable for the intended purpose.
Installation Qualification (IQ): documented verification that the equipment or systems are installed or modified & comply with the approved design of the manufacturer’s recommendations and/or user requirements.
Operational Qualification (OQ): documented verification that the equipment or systems are installed or modified & perform as intended throughout the anticipated operating ranges.
Performance Qualification (PQ): documented verification that the equipment and ancillary systems are connected & can perform effectively and reproducibly based on the approved process method and specifications.
Heating, Ventilating and Air conditioning system is used for temperature and humidity control within 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
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.
Water for Injection (Bulk)-
Characters-A clear, colorless, odorless and tasteless liquid.
solute = 4000
x = 200 g
S g. = 100 ml ,
X = 4000 ml
X = 4000 x S/100 = 200 g
Volume in ml = 75/0.1 =750 ml
In fluid dynamics, a vortex is a region within a fluid where the flow is mostly a spinning motion about an imaginary axis, straight or curved.
BFS means Blow Fill Seal. This technology usually used for sterilized product like ophthalmic drops, where container preparation, material fill and sealing all are happen at a time.
The effervescent tablet mainly consists of three components:
Lyophilization, or freeze drying, there is a water is frozen, followed by its removal from the sample, initially by sublimation (primary drying) and then by desorption (secondary drying). In this process, the moisture content of the product is reduced to such a low level that does not support biological growth or chemical reactions which gives the stability to the formulation. This technique useful in formulation development of drugs which are thermolabile and/or unstable in aqueous medium.
The primary packaging consist of those packaging components which have a direct contact with the product (i.e. bottle, cap, cap liner, label etc).
The secondary packaging mainly provides the additional physical protection necessary to endure the safe warehousing and for refill packaging.
Strip packages have at least one sealed pocket of material with each pocket containing a single dose of the product. The package is made of two layers of film or laminate material. The nature and level of protection which is required by the contained product will affect the composition of these layers.
Blister packages are composed of a base layer, with cavities called blisters which contain the pharmaceutical product, and a lid. This lid is sealed to the base layer by heat, pressure or both. They are more rigid than strip packages and are not used for powders or semi-solids. In tropical areas blister packages with an additional aluminium membrane is used which provide greater protection against high humidity.
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Introduction To Production And Operation
Plant Location And Layout
Production Planning And Control
Work Study (time And Motion Study)
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