best notes m pharmacy

1. A seminar on
Pilot Plant Scale-up
Technique of Parentrals
By
Ayesha Mulani
Under the guidance of
Mrs. A. K. Salunkhe

2. CONTENTS
 INTRODUCTION
 SCALE- UP FOR PARENTRALS
 WEARHOUSE AREA
 PRODUCTION AREA
 FORMULATION
 EQUIPMENT
 PROCESS OF MANUFACTURING
 QUALITY CONTROL TEST

3. INTRODUCTION
 Pilot plant is the intermediate plant between
the laboratory scale and production plant.
 To evaluate the effect on the process of large
scale operation and collect other data so that a
good design of larger unit may be made with
with high probability of commercial success.
 To find and examine all product or waste which
may not be seen in laboratory scale.

4. PRODUCTION AREA
 All samples should be aseptically taken during
the production.
 These measures readings the potential for
contamination into the materials

5. The materials are passed through class 100000 i.e. grade D
environment for pre sterilization .
• Transfer of materials are carried out in
air locks to avoid cross contamination
The preparation areas are supplied with HEPA
filters . there should be more than 20 air cycles per
hours.
• The preparation place is class100 area .

6.  HEPA filters-
Remove particles up to 0.3 micro meters with
the efficacy of 99.97%
HEPA filters are composed of a mat of randomly
arranged fibres.

7. TYPES OF PARENTRALS
DOSAGE FORMS
 Solution- eg. large volume parenterals (LVP)
small volume parenterals (SMP)
 Suspensions-eg. penicillin G procaine
Injectables suspension
 Emultions-eg. w/o–subcutaneous injection
o/w-intramuscular injection
 Dry powders-eg. ampicillin

8. FORMULATION
 Vehicles-
 The most commonly used solvent is water for
injection
 WFI is prepared by distillation or reverse
osmosis.
 Non aqueous vehicles-
 Peanut oil
 Corn oil
 Cotton seed oil
 Sesame oil

9.  Antioxidants-
ascorbic acid
Sodium bisulphide
Tocopherol
 Antimicrobial
Bezalalkonium chloride
Metacresol
Benzylalcohol
 Buffers
Acetates
Citrates
Phosphates

10.  Tonicity adjusting agent
Sodium chloride
Dextrose
 Surfactant
Tween 80,20
Lecithin
 Chelating agent
Sodium edetate
Citric acid

11. EQUIPMENTS

13. PROCESS OF
MANUFACTURING
 Freeze drying
The process consist of –
1. Freezing
2. Primary drying
3. Secondary drying

14.  Aseptic crystallization
Drug is dissolved in to suitable solvent and filter
through membrane filtrate
A second solvent is added for crystallization
Crystals are collected, washed, and dryed by
vacuum drying.

15.  Spray drying
The drug solution is pass through an atomizer
that creates an aerosol of small droplets of
liquid .
Aerosol comes in contact with steam of hot gas
The solvent evaporates and drug is collected in
powder form.

16. QUALITY CONTROL TEST
 Clarity test
 Sterility test
 Pyrogen test-
Rabbit test
LAL test
 Leakage test

17. PACKAGING
 Glass-
Soda lime glass
Borosilicate glass
 Plastic-
Ampoules
Vials
 automatic injectors

18. THANK YOU…