SRTM University, Nanded Contents Definition Objectives Steps in scale-up General considerations GMP considerations Advantages and Disadvantages. R & D Production Pilot Plant Scale-up: “The art of designing of prototype .. Pilot Plant scale-up techniques for Capsule Capsules are solid. Pilot plant scaleup techniques used in pharmaceutical manufacturing. Sunil Boreddy Rx. Pilot plant & scale up techniques. Nitin Kadam. What is Cancer Presentation. UCCC. Cancer PPT (From Mrs. Brenda Lee) Carla. Cancer slides. Millicent Mtshali. Cancer Powerpoint. Patty Melody. nano particles. i Nanduri.
|Published:||25 March 2017|
|PDF File Size:||21.39 Mb|
|ePub File Size:||29.9 Mb|
Providing data that can be used in making a decision on whether or not to proceed to a full-scale production process; and in the case of a positive decision, designing and constructing a full-size plant or modifying an existing plant Slide Process parameters should be evaluated and optimized.
Identification of all critical, features of a scale up process, so that it can be adequately monitored to provide assurance that the process is under pilot plant scale up techniques and that the process at each level of the scale up maintains the specified attributes originally intended.
Production rate and future market requirements. This is because a process using the same type of equipment can perform quite differently when the size of the equipment and the amount of material involved is significantly increased.
The chemical attributes of the product, its quality and efficacy should be maintained even though the production processes is modified as a result of sample size increase and equipment changes. Review of the formula: A thorough review of the each aspect of formulation is important.
PILOT PLANT SCALE- UP TECHNIQUE
Then the effect of scale-up using equipment that may subject the product to stresses of different types and degrees can more readily be predicted, or recognized. Raw materials used in the small scale production cannot necessarily be pilot plant scale up techniques representative for the large scale production Why?
The size of the equipment should be such that the experimental trials run should be relevant to the production sized batches. Steps should also be taken to ensure that all the ingredients are free of lumps and agglomerates.
Dry Blending The equipment used for blending are: V- blender Double cone blender Ribbon blender Slant cone blender Bin blender Orbiting screw blenders vertical and horizontal high intensity mixers.
Granulation The most common pilot plant scale up techniques given to justify granulating are: To impart good flow properties to the material, To increase the apparent density of the powders, To change the particle size distribution, Uniform dispersion of active ingredient.
Traditionally, wet granulation has pilot plant scale up techniques carried out using, Sigma blade mixer, Heavy-duty planetary mixer. Granulation Wet granulation can also be prepared using tumble blenders equipped with high-speed chopper blades.
Used in tablet formulations to make powders more compressible and to produce tablets that are more resistant to breakage during handling.
PILOT PLANT SCALE UP TECHNIQUES - ppt download
In some instances the binding agent imparts viscosity to the granulating solution so that transfer of fluid becomes difficult. This problem can be overcome by adding some or all binding agents in the dry powder prior to granulation.
Granulation Some granulation, when prepared in production sized equipment, take on a dough-like consistency and may have to be subdivided to a more granular and porous mass to facilitate drying. This can be accomplished by passing the wet mass through an oscillating type granulator with a suitably large screen or a hammer mill pilot plant scale up techniques either a suitably large screen or no screen at all.
PILOT -PLANT- SCALE UP |authorSTREAM
Drying The most common conventional method of drying a granulation continues to be the circulating hot air oven, which is heated pilot plant scale up techniques either steam or electricity. The important factor to consider as part of scale-up of an oven drying operation are airflow, air temperature, and the depth of the granulation on the trays.
If the granulation pilot plant scale up techniques is too deep or too dense, the drying process will be inefficient, and if soluble dyes are involved, migration of the dye to the surface of the granules. Drying times at specified temperatures and airflow rates must be established for each product, and for each particular oven load.
PILOT PLANT SCALE UP TECHNIQUES
Drying Fluidized bed dryers are an attractive alternative to the circulating hot air ovens. The important factor considered as part of scale up fluidized bed dryer are optimum loads, rate of airflow, inlet air temperature and humidity.
Particle size reduction of the dried granulation of production size batches can be carried out by passing all the material through an oscillating granulator, a pilot plant scale up techniques mill, a mechanical sieving device, or in some cases, a screening device.
This is done because some of these additives, especially magnesium stearate, tend to agglomerate when added in large quantities to the granulation in a blender.