pilot plant scale up study

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pilot plant scale up study and its significance


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Pilot plant scale up techniques and its significance:

By k.Manohar M.Pharm 1 st year VAAGESWARI COLLEGE OF PHARMACY Pilot plant scale up techniques and its significance


Plant :- It is a place were the 5 M’s like money, material, man, method and machine are brought together for the manufacturing of the products. Pilot Plant :- It is the part of the pharmaceutical industry where a lab scale formula is transformed into a viable product by development of liable and practical procedure of manufacture. Scale-up :- The art for designing of prototype using the data obtained from the pilot plant model. INTRODUCTION:

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Pilot plant studies must include a close examination of the formula to determine its ability to withstand batch scale and process modification It must also include a review of a range of relevant processing equipment to determine which would be the most compatible with the formulation as well as the most economical , simple , and reliable in producing the product

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The physical space required and the layout of related functions should be taken into account during the pilot plant phase with the intent to provide short term and long term efficiencies. The requirements , training , reporting relationships and responsibilities of personal are also factors in successful product scale up.

Steps in scale up:

Define product economics based on projected market size and competitive selling and provide guidance for allowable manufacturing costs Steps in scale up Conduct laboratory studies and scale-up planning at the same time Define key rate-controlling steps in the proposed process Conduct preliminary larger-than-laboratory studies with equipment to be used in rate-controlling step to aid in plant design

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Design and construct a pilot plant including provisions for process and environmental controls, cleaning and sanitizing systems, packaging and waste handling systems, and meeting regulatory agency requirements Evaluate pilot plant results (product and process) including process Economics to make any corrections and a decision on whether or not to proceed with a full scale plant development

General considerations:

General considerations Reporting Responsibility The formulator who developed the product can take into the production and can provide support even after transition into production has been completed R & D group with separate staffing

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Pilot plant functions can be part of a research and development group with separate staffing. This arrangement is designed to provide a responsibility to scale up formulations with in research and development ,there by providing an opportunity for critique of formulation process that is independent of the initial formulation function, the formulators who developed the product can take it into production has been completed. Some companies prefer to have the pilot plant and technical service group organizationally separate from research and reporting instead to operations side of the business

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What ever the reporting arrangement ,the goal of a pilot plant is to facilitate the transfer of a product from the laboratory into production. The effectiveness of the pilot plant is determined by the ease with which new products or processes are brought into routine production. This can be achieved if a good relationship exists between the pilot plant group and the other groups with which they interact ,namely, research and development, processing ,packing ,engineering , quality assurance ,regulatory and marketing

Personal requirements:

The qualification required for a position in a pilot plant organization are a blend of good theoretical knowledge of pharmaceutics and some practical experience in the pharmaceutical industry .additionally he should have well communication skills. For these reasons ,successful pilot plant organizations frequently include scientists with experience in both areas Personal requirements

Space requirements:

A pilot plant has four types of space requirements 1. Administration and information processing 2.Physical testing area 3.Standard pilot plant equipment floor space 4.Storage area Space requi rements

Administration room:

Adequate office and desk space must be provided for both the scientists and technicians , this should be adjacent to the work area but sufficiently isolated to permit people to work. There should also be space for a computer terminal for convenient data entry and retrieval as well as archives for stability data protocols and historical files. Administration room

Physical testing area:

The second required area is an adequate working area in which samples can be laid out and examined and where physical tests on these samples can be performed. This area should provide permanent bench top space for routinely used physical testing equipment (e.g,balance , ph meter , and viscometer) Physical testing area

Floor space:

The third area is discrete plant space where equipment needed for manufacturing all types of pharmaceutical dosage forms is located The equipment should be available in a variety of sizes known to be representative of production capability Utilization of this area is most efficient when it is sub divided in to areas for solid dosage forms, semi solid dosage forms , liquid preparation and sterile products Floor space

Storage area:

The forth area and the one most often described as in adequate is storage space. Separate provisions should be made for the storage of active ingredients & excipients. These should be further segregated in to approved and un approved areas according to GMPs . There should be generous storage areas for in process materials, finished bulk products from the pilot plant, and material from experimental scale up batches made in production , which for GMP reasons cannot be stored in operations storage areas. Storage area

Review of formula:

Through review of each aspect of the formulation is important and should be carried out early in a scalar process. The purpose of each ingredient and its contribution to the final product manufactured on small scale laboratory equipment should be understand then the effect of scale up using equipment that may subject the product to stresses of types and different types and degrees can be more readily predicted, or recognized when they actually occur. Review of formula

Raw materials:

One responsibility of the pilot plant function is the approval and validation of the active and excipient raw materials used in pharmaceutical products. This is necessary because the raw materials used during small scale formulation trails may not be representative of the large volume shipments of materials used in large scale production, or because active ingredients , which may only have been prepared on a laboratory scale, are also being subjected to scale up to meet the rising needs of the product. Raw materials

Relevant processing equipment:

It is almost certain that most formulation development work has been carried out on small , relatively simple laboratory equipment . During subsequent scale up ,alternative manufacturing equipment should be considered Based on the known processing characteristics of the product, the equipment that promises to be the most ecomomical,the simplest and the most efficient ,and the most capable of consistently producing product with in the proposed specifications should be evaluated. Relevant processing equipment

Production rates:

The immediate as well as the future market requirements must be considered when determining the production rates and the type and size of production equipment needed. The equipment and process should be chosen so as to produce batches at a frequency that takes into consideration product loss in the equipment during manufacturing Production rates

Process Evaluation:

This step is to evaluate the process critically and to optimize its performance based on the evaluation items that should be examined include the following Order of mixing of components Mixing speed Mixing time Rate of addition of granulating agents, solvents, solutions of drug etc. Heating and cooling Rates Filters size (liquids) Screen size(solids) Drying temp.And drying time Process Evaluation

Master Manufacturing Procedures:

The manner in which the manufacturing directions , the chemical weigh sheet , the sample directions , and in process and finished product specifications The weight sheet should clearly identify the chemicals required In a batch. To prevent confusion the names and identifying nos. for the ingredients should be used on batch records. The process directions should be precise and explicit. A manufacturing procedure should be written by the actual operator. Master Manufacturing Procedures

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Various specifications like addition rates, mixing time, mixing speed, heating, and cooling rates, temperature, storing of the finished product samples should be mentioned in the batch record directions. A check list of GMP items that should be part of scale up or new product or process introduction includes the following


The term GMP practice means different things to different people , there are FDA guidelines describing GMP , but even these can and are interpreted differently by people in the FDA and industry. GMP CONSIDERATIONS

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Equipment qualification Process validation Regularly schedule preventative maintenance Regularly process review & revalidation Relevant written standard operating procedures The use of competent technically qualified personnel Adequate provision for training of personnel A well-defined technology transfer system Validated cleaning procedures. An orderly arrangement of equipment so as to ease material flow & prevent cross- contamination


Members of the production and quality control divisions can readily observe scale up runs. Supplies of excipients & drugs, cleared by the quality control division, can be drawn from the more spacious areas provided to the production division. Access to engineering department personnel is provided for equipment installation, maintenance and repair. Advantages

Disadvantages :

The frequency of direct interaction of the formulator with the production personnel in the manufacturing area will be reduced. Any problem in manufacturing will be directed towards it’s own pilot-plant personnel's. Disadvantages


The theory & practice of industrial pharmacy by Leon Lachman, Herbert A. Lieberman, www.google.com References

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