Download - Quali and quant layout nitin
GUIDED BY:
Dr. M. R. PATEL
PRESENTEDE BY:
NITINKUMAR S. PARMARM. PHARM – I (2013-14)ROLL NO. - 06
DEPARTMENT OF PHARMACEUTICSSHRI B. M. SHAH COLLEGE OF PHARMACEUTICAL EDUCATION AND REASERCH, MODASA-2013
SHRI B.M.C.P.E.R, MODASA
Contents
IntroductionAdvantages of semisolid dosage formClassification Plant layout
Qualitative Plant Layout for semisolid Quantitative Plant Layout for semisolid
Plant layout for manufacturing of suppositoryReferences
SHRI B.M.C.P.E.R, MODASA
INTRODUCTION
SHRI B.M.C.P.E.R, MODASA
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.
DEFINITION
SHRI B.M.C.P.E.R, MODASA
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
Classification
SHRI B.M.C.P.E.R, MODASA
Semisolid dosage forms intended for topical application
SHRI B.M.C.P.E.R, MODASA
Plant layout
Requirements of plant as per schedule M
External Preparations1. 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 Suppositories1. 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
Qualitative Plant Layout for semisolid
IPQC
Waxmeltingmixing
SHRI B.M.C.P.E.R, MODASA
Ointment/Cream manufacturing & Processing plant
SHRI B.M.C.P.E.R, MODASA
Quantitative Layout for cream
25 Lts. to 10000 Lts. (2000 L)
Plant area:Raw material storage area: 18.5sq. mt.
Manufacturing area: 40.8 sq. mt.
Filling area:27 sq. mt. Packing & Labeling area:46.8 sq. mt. Final product storage area:14 sq. mt.
oilyAq.mixer
Tube filling machine
(500 KG)
SHRI B.M.C.P.E.R, MODASA
Quantitative Layout
• Plant Capacity: 10,000 Tubes/Day
• Raw Material Quantity:1. For preparing: 10000 Tubes (20 gm each)2. Total mass needed: about 225 Kg3. Oily phase(75%): 170 kg4. 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
General Corridor
entry
Male change room
Female change room
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API’s
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Raw material storage
Suppositories and pessaries manufacturing
area
QC
Steam generator
for heating
Storage of various moulds
Vessels stores
Storage of containers
Freezing area
Corridor
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Off
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Plant layout for manufacturing of suppository
SHRI B.M.C.P.E.R, MODASA
Specific requirement for manufacturing of topical
preparation
1. Manufacturing area under suitable AIR LOCK. Outside air lock INSECTOCUTORS shall be installed.
2. The air to this manufacturing area shall be filtered through at least 20μ air filters and shall be air-conditioned.
3. An EXHAUST SYSTEM of suitable capacity.4. NO RAGS OR DUSTERS shall be used in process
of cleaning & drying.5. Water used in compounding shall be PURIFIED
WATER IP6. Powders SUITABLY SIEVED, before use.7. Heating vehicles & base like petroleum jelly
shall be done in SEPARATE MIXING AREA.8. The temperature of manufacturing area shall
NOT EXCEED 30˚C.
SHRI B.M.C.P.E.R, MODASA
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.com5. www.kotharipharma.com6. www.riddhipharma.com7. www.keimachines.com8. www.vabatrading.nl9. www.packexpo.com10.www.in-pharmatechnology.com
SHRI B.M.C.P.E.R, MODASA
Thank You
SHRI B.M.C.P.E.R, MODASA