Pilot Plant - It can be understood as a small-scale production system or a pre-commercial system of the giant pharmaceutical industry. Here, a small preliminary lab-scale formula is developed and transformed into an operational product by the development of the liable and practical procedure of manufacture.
Scale-up - The art designing of a prototype to increase the batch size of a product using the data obtained from the pilot plant model.
Objectives:
Scale-up - The art designing of a prototype to increase the batch size of a product using the data obtained from the pilot plant model.
Objectives:
- Before investing a large sum of money on a production unit this small preliminary lab-scale formula can be carried out on a model of the proposed plant.
- To conduct an examination of the formula to check its robustness and ability to withstand large scale or Batch-scale production and if process modification is needed.
- To conduct an evaluation of equipment and process validation.
- Assessment of the crucial or vital step of the process.
- Guidelines to be followed strictly for production and process controls.
- Master manufacturing formula is provided with instructions for manufacturing procedure.
- To avoid or minimize the scale-up problems.
- Evaluation of a product and process validation on an intermediary scale can be carried out by a pilot plant setup before investing large amounts of money to full-scale production.
- It is not feasible to predict the effects of a many-fold increase in the scale of batch production without a pilot plant study.
- It is beyond everyone’s scope to design a large-scale manufacturing unit from laboratory data alone without any degree of relevant success.
Pilot plant scale-up checkpoints for liquid orals
- Personal requirements: A person with good theoretical knowledge of pharmaceutics with a perfect blend of rich practical experience in liquid orals manufacturing are the basic requirement.
- Space requirements:
- Administration and information processing: A place for any paper work, any discussion, documentation purpose desk, space for meetings , computer junction
- Physical testing area: A place where samples are laid out, examined and physically tested.
- Equipment floor space: A place designated for equipments needed for manufacturing liquid orals.
- Storage area: It includes storage for active ingredients and equipment, inprocess materials, finished bulk products, packaging materials.
Raw material → Weighing and measuring → Mixing (Addition of distilled water) → Filling → Packing (Finished Product Storage) → Quality Assurance
Pilot plant scale-up checkpoints for semi-solids
Steps of the semisolids manufacturing process:- Pastes, gels, ointment, and creams are categorized as semi-solid dosage forms with higher viscosities.
- The scale-up considerations of these products include many of the same factors that must be considered in the scale-up of the liquid orals.
- A concerning factor is the high viscosity of semisolids which play a definitive step in the scale-up technique. For example - Ointments or creams with homogenous mixture can be manufactured by the use of specialized mixers that are not used for liquid suspensions.
- The mixing equipment which is used for semisolids must be capable of continuously rotating the semisolids mass or to prevent sticking from the outside walls of the mixing equipment.
- Mixing of ingredients involves the uniform distribution of the ingredients and brings about a heat transfer during the heating and cooling steps.
- Planning of requirement of material
- Preparation of semisolids
- Filling and Packing
- Quality Assurance
Pilot plant scale-up checkpoints for solids:
1. Material handling system
1. Material handling system
- In large-scale production, proper handling of materials is necessary.
- Accurate quantity of the ingredient should be delivered to the destination.
- Selection of the the type of system depends on the characteristics of the materials.
- Different material handling systems are vacuum loading systems, devices to lift & tilt drums, metering pumps, screw feed systems.
2. Dry Blending
- Granulated powders must be well blended to ensure proper distribution of drug.
- An inadequate blending of powders could result in uneven portion of the batch which result in either high or low in potency.
- To ensure that all the ingredients are free of lumps and agglomerates prior to blending, proper steps should be taken care of or else flow problems can occur.
- Prior screening and/or milling of the ingredients should be carried out before blending.
3. Granulation
Below are the few key points which explains the importance of pilot plant scale up as follow:
- The process involves the transformation of fine powders into free-flowing powders that are definitely easy to compress.
- Used in tablet formulations to make powders more compressible and resistant to breakage during handling.
- Drying of granulation takes place by circulating hot air oven, which is heated by either steam or electricity.
- Drying times at specified temperatures and airflow rates must be taken care of for each product.
- The forces used for slugging should be taken care of, the diameter of the punches and the sizing and screening operations.
- Optimization of these variables affects particle size and particle distribution.
- The process involves where the granulation can be compressed on a high-speed tablet press and produce tablets.
- Tablet formulation can be put into test to check whether the granulation can be compressed on a high-speed tablet press.
- In-process quality control facilities to check the formulations are as follow:
- There are also separate areas for carrying out:
- Stability studies
- Accelerated stability studies
- accelerated light stability studies
- forced degradation studies in accordance with ICH guidelines
Below are the few key points which explains the importance of pilot plant scale up as follow:
- Examination of formulae can be carried out.
- Review of range of relevant processing equipments.
- The specification of the raw materials can be understood.
- Production rates can be checked.
- The physical space area required can be checked.
- Appropriate records and reports can be obtained to support GMP.
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