This document provides an overview of non-sterile manufacturing processes. It discusses the manufacture of tablets, capsules, liquid orals, and external preparations. The key requirements for the manufacturing area include controlled temperature, humidity, air filtration, cleaning and sanitization. Tablet manufacturing involves mixing, granulation, drying, compression and coating. Capsule manufacturing uses filling machines. Liquid oral production requires mixing tanks, filtration and bottling equipment. External preparations are made using mixing tanks, mills and filling equipment.

1. Non sterile manufacture
Prepare by: Yannawar P.D ( M.pharm)
DCOP, Latur

2. Content
 Introduction
 Manufacture of table, capsule
 Manufacture of liquid orals
 manufacture of externals

3. Introduction
 Definition:
 The products or drugs that do not require sterilization
are called as Non-sterile Manufacturing.
• Manufacturing operation are generally economical
when hospital is having large requirement.
• Hospitals interested in the manufacture of drugs are required
to take a proper license and follow the rules framed in schedule M.

4. Specific requirement for manufacturing of
non sterile products area
 The premises and equipment should be designed, constructed and maintained to suit the manufacturing of
non sterile preparation
 Manufacturing area should have entry through double door airlock facility
 The air to this manufacturing area should be filtered through at least 20 micron air filter
 Temperature and relative humidity should be control, monitored and recorded
 The equipment used are designed and maintained to prevent product from contamination
 Water used in compounding should be purified water IP.
 production area should be cleaned and sanitized at the end of every production

5. MANUFACTURING
 Manufacturing of tablet , capsule
 Manufacture of liquids
1. Monophasic liquid dosage form
Mixture, syrup, elixirs
2. Biphasic liquid dosage form
Suspension, emulsion
 Manufacture of external preparations
Ointment, paste, cream, gel

6. Manufacture of tablet
Definition
Tablet is defined as compressed unit solid dosage form containing API( drug) with or without excipient
Compressibility is ability of powder to form a compact mass after applying pressure.
The granulation of powder increase the compressibility
Methods of granulations:
Wet granulation
Dry granulation
Direct compression

8. Name the equipment required for manufacturing of tablets.
Sr.no. Equipment Examples
1 Mixer/Blender Sigma blade mixer, tumbling mixers, Ribbon blenders
2 Grinder/Shifter Cutter mill, Hammer mill.
3 Dryers Tray dryers, Fluidized bed dryers.
4 Compression
machine
Single punch, Double punch, Rotary
5 Coating machine Pan coating, Spray coating pans, Fill coating
Machine and Polishing pan.
6 Packaging Machine Blister/ strip packaging machine

9. .

10. Capsule
 Capsules are solid dosage form in which drug substance enclosed within either hard gelation or soft
gelatin shell.
 Equipment required for manufacturing of capsule
 In hospital capsule's are prepared using
1. hand operated capsule filling machine
2. Mixing and blending equipment
3. Capsule filling unit
4. Capsule counters

11. Facilities required for manufacture of
tablet, powders and capsules
 The tablet, capsules and powders need to be manufacture in controlled environment
 There should be space where personnel's can change into working cloths
 There should be separate area for cleaning of equipment's
 Each area should be equipped with self closing door
 The working area should be ventilated where air entering is passes through purification system
 Routine environmental inspection should be done.

12. Liquid orals definition
 Syrup:
Syrups are concentrated solutions of sugar in water or other aqueous liquid.
 elixirs
clear, sweetened hydro alcoholic liquids intended for oral use containing flavoring substances or active medicinal
agents.
 emulsion
A Pharmaceutical suspension is a disperse system in which internal phase is dispersed uniformly as finely divided
insoluble particles throughout the external phase
 suspension
emulsion is a two-phase system in which one liquid is dispersed in the form of small globules throughout another
liquid.

13. Manufacture of liquid orals
 Equipment required for manufacture of liquid orals
1. Mixing and storage tanks
2. Jacketed kettles/ ss tank
3. Colloidal mill or emulsifier
4. Filtration equipment
5. Semi automatic or automatic bottle filling machine
6. Water distillation unit
7. Quality control equipment for liquid orals

14. Definition of external preparation
 Ointment:
Ointments are homogenous, translucent, viscous semi-solid preparations, most commonly a greasy, thick oil (oil
80% - water 20%) intended for external application to the skin or mucous membrane.
 Paste
Pastes are homogeneous semisolid dosage form contains high conc. Of insoluble powder substance ( not less
than 20%) dispersed in the suitable base
 Gel
Jellies are transparent or translucent non-greasy semisolid dosage form
 Cream
creams are semisolid dosage forms containing more than 20% water or volatile components and typically less
than 50% hydrocarbons, waxes, or polyols as vehicles.

15. Manufacture of externals
 Equipment required for manufacture of externals
1. Mixing and storage tank ( SS )
2. Jacketed kettle ( steam, gas or electrically heated )
3. Mixer
4. Ointment mill or triple roller mill
5. Liquid filling equipment
6. Jar or tube filling equipment