TRIPASS XR تري باس

 

Fig. 2.1: Reporting responsibilities under general considerations

10 Industrial Pharmacy II

scale-up and the pilot-plant should have practical experience in pilot-plant operations.

The level of education and type of education should be matched within the group

because they have to understand each other perspective. The group should have

personnel from different disciplines like engineering, economics, management,

production, etc. The scientists with experience in pilot-plant production as well as

actual production area should be preferred. The number of personnel required depends

upon the number of products being supported and the level of support.

2.1.3 Space Requirements

There are four types of space requirements of a pilot-plant

i. Administrative and information processing

ii. Physical testing area

iii. Standard pilot-plant equipment floor space

iv. Storage area

Administrative and Information Processing

i. Adequate space should be there.

ii. Scientist and technicians should have adequate office and desk space.

iii. There should be proper facilities so that scientists and technicians can do proper

documentation of their activities and observation.

iv. It should be near the work area but away from undue distraction.

Physical Testing Area

i. The space of physical testing area should be adequate so that analysis and physical

testing of samples can be done. It helps in early detection of a production error.

ii. There should be permanent benchtop space for testing equipment (for physical

testing) balances, viscometer, pH meter, etc.

Standard Pilot-Plant Equipment Floor Space

i. The equipment should be in a variety of sizes so as to enable the production of a

product in a different capacity.

ii. There should be discrete pilot-plant space where the equipment need for

manufacturing of all type of dosage forms/formulations can be kept.

iii. There should be space for the cleaning of equipment.

iv. The equipment should be portable so that it can be used when and wherever

possible. This will also help in the storage of equipment in a small storeroom.

v. The production equipment should be of intermediate-size, as well as full-scale

production sized so that the effect of scale-up of research formulations and the

process can be evaluated.

Storage Area

i. There should be two separate areas—one for active ingredients and another one

for excipients so as to avoid intermixing.

ii. Different areas should be provided for in-process materials, products from pilotplant, and materials from scale-up batches.

iii. There should also be the availability of a storage area for packing material.

General Considerations and Pilot-Plant Considerations for Different Dosage Forms 11

2.1.4 Review of the Formula

A thorough and critical review of each prospect of the formulation is important. It is

done to:

i. Understand the purpose of each ingredient and its contribution to the final product

that is manufactured on small-scale laboratory equipment.

ii. Understand the degree and type of stress on the product that can be the result of

scale-up.