This document presents information on qualitative and quantitative plant layouts for semisolid dosage form manufacturing. It includes classifications of semisolid dosage forms, advantages, and requirements for external preparation and suppository plants based on Schedule M guidelines. Plant layout diagrams show designated areas for raw materials, manufacturing, filling, packaging, storage, and quality control. Specific requirements for topical preparation plants include manufacturing in an airlocked area with filtered air, exhaust systems, and temperature control.

1. GUIDED BY:
Dr. M. R. PATEL
PRESENTEDE BY:
NITINKUMAR S. PARMAR
M. PHARM – I (2013-14)
ROLL NO. - 06
DEPARTMENT OF PHARMACEUTICS
SHRI B. M. SHAH COLLEGE OF PHARMACEUTICAL EDUCATION AND REASERCH, MODASA-2013
SHRI B.M.C.P.E.R, MODASA

2. Contents
Introduction
Advantages of semisolid dosage form
Classification
Plant layout
Qualitative Plant Layout for semisolid
 Quantitative Plant Layout for semisolid
Plant layout for manufacturing of suppository
References

SHRI B.M.C.P.E.R, MODASA

3. INTRODUCTION
 Semisolid pharmaceutical systems comprise a body of products, which
when applied to the skin or accessible mucous membranes tend to
alleviate or treat a pathological condition or offer protection against a
harmful environment.
 They have the property to cling to the skin or mucous membrane for a
protracted period of time to exert their therapeutic effect through
protection and occlusion. The adhesion is due to their plastic rheological
behavior which allows semisolid to retain their shape and cling as film
until acted upon by an outside force.
 Semisolid dosage forms usually are intended for localized drug delivery. In
the past few years, however, these forms also have been explored for the
systemic delivery of various drugs. Semisolids constitute a significant
proportion of pharmaceutical dosage forms. They can be applied topically
to the skin, cornea, rectal tissue, nasal mucosa, vagina, buccaltissue,
urethral membrane, and external ear lining.
SHRI B.M.C.P.E.R, MODASA

4. DEFINITION
 Semisolid dosage forms are dermatological products of semisolid
consistency and applied to skin for therapeutic or protective
action or cosmetic function.
Advantages of semisolid dosage form
 Avoidance of first pass metabolism
 Avoidance of gastro intestinal incompatibility
 Predictable and extended duration of activity
 Delivery via the skin route is an interesting option because route is
convenient and safe
 Provide suitability for self administration
 Enhance therapeutic efficacy of drugs
 Avoiding the fluctuation in drug levels
 Inter and intra patient variations
 Maintain plasma concentration of potent drugs
 Termination of therapy is easy at any point of time
SHRI B.M.C.P.E.R, MODASA

5. Classification
SHRI B.M.C.P.E.R, MODASA

6. Semisolid dosage forms intended for topical
application
SHRI B.M.C.P.E.R, MODASA

7. Plant layout
Requirements of plant as per schedule M
External Preparations
1. A minimum area of 30 square meters for basic
installation of 10 square meters for Ancillary area
is recommended.
2. Areas for formulations meant for external use and
internal use shall be separately provided to avoid
mix-up.
Pessaries and Suppositories
1. A minimum area of 20 square meters is
recommended to allow for the basic installation.
2. In the case of Pessaries manufactured by
granulation and compression.
SHRI B.M.C.P.E.R, MODASA

8. Qualitative Plant Layout for semisolid
IPQC
Wax
mixing melting
SHRI B.M.C.P.E.R, MODASA

9. Ointment/Cream manufacturing & Processing plant
SHRI B.M.C.P.E.R, MODASA

10. Quantitative Layout for cream
Plant area:
Raw material
storage area:
18.5sq. mt.
25 Lts.
to 10000
Lts.
(2000 L)
Manufacturing area:
40.8 sq. mt.
Tube filling machine
Filling area:27 sq.
mt.
Packing & Labeling
area:46.8 sq. mt.
Final product
storage area:14 sq.
mt.
SHRI B.M.C.P.E.R, MODASA
mixer
Aq. (500 KG)
oily

11. Quantitative Layout
• Plant Capacity: 10,000 Tubes/Day
•
1.
2.
3.
4.
Raw Material Quantity:
For preparing: 10000 Tubes (20 gm each)
Total mass needed: about 225 Kg
Oily phase(75%): 170 kg
Aq. phase + Drug(25%): 55 kg
•
•
•
•
Capacity of equipment:
Mixing capacity of mixer 100 kg /shift
Tube filling machine output 60/80 tubes pm.
3600 tubes per hr.(3 hr.)
SHRI B.M.C.P.E.R, MODASA

12. Melting area
IPQC
Suppositories
and pessaries
manufacturing
area
General Corridor
SHRI B.M.C.P.E.R, MODASA
Steam
generator
for
heating
Freezing
area
Storage
of
container
s
Quarantine area
machine
IPQC for packed
suppositories
QC
Weighing
Storage of various
moulds
Corridor
line packing in
corrugated box
Vessels
stores
Corrugated box packing
Corridor
Raw
material
storage
Storage of
product
despatch
Female
change
room
storage
Office
Male
e chang
n e room
t
r
y
API’s
Packing
Raw material
entry
Plant layout for manufacturing of suppository

13. Specific requirement for
manufacturing of topical preparation
1.
2.
3.
4.
5.
6.
7.
8.
Manufacturing area under suitable AIR LOCK.
Outside air lock INSECTOCUTORS shall be installed.
The air to this manufacturing area shall be filtered
through at least 20μ air filters and shall be airconditioned.
An EXHAUST SYSTEM of suitable capacity.
NO RAGS OR DUSTERS shall be used in process of
cleaning & drying.
Water used in compounding shall be PURIFIED
WATER IP
Powders SUITABLY SIEVED, before use.
Heating vehicles & base like petroleum jelly shall be
done in SEPARATE MIXING AREA.
The temperature of manufacturing area shall NOT
EXCEED 30˚C.
SHRI B.M.C.P.E.R, MODASA

14. References
1. Drug and Cosmetic act, 1940 page no. 432 -434.
2. Pharmaceutical Dosage forms: Disperse System
Vol: 3 Edited
3. Herbert A. Lieberman, Martin M.Rieger, Gilbert
S. Banker
4. www.wintechpharmachem.com
5. www.kotharipharma.com
6. www.riddhipharma.com
7. www.keimachines.com
8. www.vabatrading.nl
9. www.packexpo.com
10. www.in-pharmatechnology.com
SHRI B.M.C.P.E.R, MODASA

15. Thank You
SHRI B.M.C.P.E.R, MODASA