A hospital may manufacture sterile and non-sterile products internally based on economic factors and patient needs. For sterile products like parenterals, the hospital needs facilities for clean rooms, environmental controls, and sterilization methods like UV irradiation. Production planning involves cleaning equipment and containers, preparing solutions/suspensions, filtration, filling, sealing, and sterility testing. Non-sterile manufacturing follows less stringent rules but can still be economical for high-volume needs like oral liquids. The type and size of a hospital determines what products it manufactures internally.

1. HOSPITAL
MANUFACTURING
Presented By,
Renatt.c.francis
First Year M.pharm
Dept. of Pharmacy Practice

2. • Type of product manufactured may vary from hospital to
hospital.
• A large sized hospital deals with critical patients in addition
to others.
• In the critical patients, it is very common to use parenteral
preparations that are required in emergency.
• The time and quantity is of the utmost importance. Many
hospitals go for manufacture of sterile preparation with in
hospital.

3. Economic consideration
Factors which determine the economy of a
hospital
1. Material requirement
2. Manufacturing requirement
3. Manufacturing staff
4. Manufacturing capacity
5. Manufacturing equipment
6. Operating cost

4. MANUFACTURING PRACTICE AND
PRODUCTION CONTROL
(1)Sterile manufacture
(2)Non- sterile manufacture

5. Sterile Manufacture
• Large and small volume parenteral:
The volume of injectable fluids vary greatly from fractions of millilitre to several
hundred millilitre. IV fluids vary from one ml to 500 ml, or more than 500 ml. IV fluids
of 500 ml and above are called as large volume parenteral (LVP).
• Facilities and Requirements
• Facilities :- maximum degree of cleanliness
• Environmental control
• Traffic control
• Maintenance :- at the end of working or night.
• Disinfection
• Irradiation :- UV rays
• Air cleaning
- Conventional clean room systems
- Laminar flow clean room systems

6. Layout of sterile products area

7. Formulation of parenterals
• Vehicles
- Aqueous vehicle
- Non Aqueous vehicles :- oils, alcohol.
• Anti bacterial agents
• Anti oxidants
• Buffers

8. Production Planning & Processing
• Cleaning of equipments
• Cleaning of containers and closures
• Preparation of solution or suspension
• Filtration
• Filling of the product in ampoule/ vial
• Sealing
• Sterilization
• Test for quality control

9. Test for quality control
• Sterility test.
• Clarity test.
• Leakage test.
• Pyrogen test.

10. Non Sterile Manufacture
• Manufacturing operations are generally
economical when the hospital is having large
requirements. Hospitals interested in the
manufacture of drugs are required to take a
proper license and follow the rules framed in
schedule M.

11. Manufacturing of liquid orals
• Monophasic liquid dosage forms :- mixtures,
syrups and elixirs.
• Biphasic liquid dosage forms :- suspensions
and emulsions.
Manufacturing of preparations for external use
• Ointments
• Pastes
• creams

12. References
• A Text book of Hospital Pharmacy, By B.S Shaa,
Page no : 176- 182.
• A Text Book of Hospital and Clinical Pharmacy,
By Dr. Pratibha Nand, Page no : 95- 122.