Industrial Pharmacy Practice I

Question 1

Classify materials for construction and plant design.

Answer 1

1. Non-metals:
   a) Organic:
   i) Rubber
   ii) Plastic
   b) Inorganic:
   i) Glass
   ii) Glassed Steel
2. Metals:
   a) Ferrous:
   i) Cast iron
   ii) Carbon Steel
   iii) Stainless Steel
   b) Non-ferrous:
   i) Aluminium
   ii) Lead

Question 2

Different factors are considered when purchasing materials for storage and construction. These factors are broadly classified into:

Answer 2

i. Chemical factors
ii. Physical factors
iii. Economic factors

Question 3

Discuss the chemical factors considered when choosing construction and storage materials.

Answer 3

A poor choice of construction materials may lead to corrosion of equipment and containers, and the contamination of products.

• Iron contamination can change the colour of products (e.g., gelatin capsules) and catalyze some reactions that may accelerate degradation
• The leaching of glass may make the aqueous product alkaline, which may catalyze the decomposition of the product
• Heavy metals like lead inactivate penicillin
• Products, such as strong acids, strong alkalis, tannins and strong oxidizing agents may corrode construction material with prolonged contact.

Question 4

Discuss the physical factors considered when choosing construction and storage materials.

Answer 4

a. Strength: a material must have sufficient strength to withstand the pressure and stress involved in the manufacturing process. Iron and steel satisfy these properties. Aerosol containers must withstand very high pressure so lacquered tin containers are used.

b. Mass: Light weight materials such as plastic, aluminium and paper are used in the packaging of pharmaceuticals.

c. Thermal conductivity: Materials with good thermal conductivity, such as iron, copper, aluminium, are used in the operation of evaporators, dryers, magnetic stirrers and water baths.

d. Cleaning: Surfaces should be made of materials that are easy to clean.

e. Sterilisation: Materials must be able to withstand the high temperatures of sterilisation.

f. Transparency
g. Thermal expansion
h. Ease of fabrication

Question 5

Discuss the economical factors considered when choosing construction and storage materials.

Answer 5

Several materials may be suitable for construction based on their physical and chemical properties. However, materials with low maintenance cost and high durability are preferred.

Question 6

What is a pharmaceutical plant layout?

Answer 6

Pharmaceutical plant layout refers to the strategic floor plan of a pharmaceutical manufacturing facility, which details the arrangement of spaces, machinery and equipment to streamline the production process and ensure the efficient flow of materials and personnel.

The design must align with NAFDAC and WHO regulatory standards.

Question 7

Highlight 4 requirements of the location of a pharmaceutical plant

Answer 7

• The premises should be situated in an environment that presents to risk of material or product contamination.
• The plant should be designed to ensure the logical flow of materials and personnel
• It should be designed and equipped to afford maximum protection against the entry of animals
• The premises should be designed to facilitate good sanitation
• The premises should be designed to allow for good process flow

Question 8

List the industrial plant areas and their requirements.

Answer 8

1. Production area:
   - should be well lit, particularly where visual on-line controls are carried out
   - should be effectively ventilated, with air control facilities suited to the products handled, operations undertaken and the external environment
2. Weighing area:
   - the weighing of starting materials and yield should be carried out in separated weighing areas designed for that use
   - may be part of either storage or production areas
3. Storage area:
   - should be of sufficient capacity to allow orderly storage of various categories of materials and products with segregation
4. Quality control area:
   - should be separated from production areas
   - biological, microbial and radioisotope test areas should be separated from each other.
5. Ancillary area:
   - includes rest and refreshment rooms, washing and toilet facilities, and changing and clothes storing facilities
   - should be separated from production area
6. Dedicated area:
   - dedicated facilities must be available for the production of highly sensitizing materials e.g., beta-lactams and biological preparations to minimise risk of medical hazard from cross-contamination,

Question 9

Categories of materials and products stored in the storage area

Answer 9

i. starting material
ii. packaging material
iii. intermediates
iv. bulk and finished products
v. products in quarantine
vi. rejected, returned or recalled products

Question 10

Mention 4 other requirements of a production facility.

Answer 10

i. Lighting
ii. HVAC system
iii. Water supply (must meet NIS standard for drinking water)
iv. Sewage and refuse
v. Sanitation