Schedule M-II

Schedules: Schedule ASchedule BSchedule CSchedule DSchedule E1Schedule FSchedule GSchedule HSchedule H1, Schedule I, Schedule JSchedule KSchedule L1Schedule MSchedule M1Schedule M2Schedule M3Schedule NSchedule OSchedule PSchedule QSchedule RSchedule SSchedule TSchedule USchedule V, Schedule W, Schedule XSchedule Y

Schedule M-II (Rule 139):
Schedule M-II describes the requirements of factory premises for manufacture of cosmetics.
1.       General Requirements
·         Location and surroundings
·         Buildings
·         Water Supply
·         Disposal of water
·         Health, clothing and sanitary requirements of the staff
·         Medical Services
·         Worker Benches
·         Adequate Facilities
2.       Requirements of Plant and Equipments
The following equipment, area and other requirements are recommended for the manufacture of:
A. Powders:− Face powder, cake make-up, compacts, face packs, masks and rouges, etc.

Equipment:
(a)Powder mixer of suitable type provided with a dust collector
(b)Perfume and colour blender
(c)Sifter with sieves of suitable mesh size
(d)Ball mill or suitable grinder
(e) Trays and scoops (stainless steel)
(f) Filling and sealing equipment provided with dust extractor.
(g) For compacts: (i) a separate mixer, (ii) compact pressing machine
(h)Weighing and measuring devices (i) Storage tanks.

An area of 15 square meters is recommended. The section is to be provided with adequate exhaust fans.

B. Creams,   lotions,   emulsions,   pastes,   cleansing   milks,   shampoos,   pomade, brilliantine, shaving creams and hair-oils etc.
 (a) Mixing and storage tanks of suitable materials
(b) Heating kettle-steam, gas or electrically heated
(c) Suitable agitator
(d)Colloidal mill or homogeniser (wherever necessary)
(e)Triple roller mill (wherever necessary)
 (f)Filling and sealing equipment
(g)Weighing and measuring devices.

An area of 25 square meters is recommended.

C. Nail Polishes and Nail lacquers.
 1. Equipment:
 (a) A suitable mixer
(b) Storage tanks
(c) Filling machine- hand operated or power driven.
(d)Weighing and measuring devices.
 An area of 15 square meters is recommended. The section shall be provided with flameproof exhaust system.
 2. Premises: The following are the special requirements related to Nail Polishes and Nail Lacquers:
 (a) It shall be situated in an industrial area.
(b) It shall be separate from other cosmetic-manufacturing areas by metal/brick partition up to ceiling.
(c) Floors, walls, ceiling and doors shall be fireproof.
(d) Smoking, cooking and dwelling shall not be permitted and no naked flame shall be brought in the premises.
(e) All electrical wiring and connections shall be concealed and main electric switch shall be outside the manufacturing area.
(f) All equipment, furniture and light fittings in the section shall be flameproof.
(g) Fire  extinguisher  like  foam  and  dry  powder  and  sufficient  number  of  buckets containing sand shall be provided.
(h)All doors of the section shall open outwards.
 3.    Storage: All explosive solvents and ingredients shall be stored in metal cupboards or in a separate enclosed area.
4.    Manufacture:
 (a)  Manufacture of lacquer shall not be undertaken unless the above conditions are complied with.
(b)Workers shall be asked to wear shoes with rubber soles in the section.
 5.     Other requirements:
 No objection certificate from the local Fire Brigade Authorities shall be furnished.

D. Lipsticks and Lip-gloss, etc.
1.  Equipment
(a) Vertical mixer
(b) Jacketted kettle - steam, gas or electrically heated.
(c) Mixing vessel (stainless steel).
(d) Triple roller mill/Ball mill.
(e) Moulds with refrigeration facility.
(f) Weighing and measuring devices.
An area of 15 square meters is recommended.

E. Depilatories.
1. Equipment:
(a) Mixing tanks.
(b) Mixer
(c) Triple roller mill or homogeniser (where necessary).
(d) Filling and sealing equipment.
(e)Weighing and measuring devices.
(f) Moulds (where necessary).
An area of 10 square meters is recommended.

F. Preparations used for Eyes:
Such preparations shall be manufactured under strict hygienic conditions to ensure that these are safe for use.
1.       Eyebrows, Eyelashes, Eyeliners, etc.
Equipment:
(a)Mixing tanks.
(b) A suitable mixer.
(c) Homogeniser (where necessary)
(d)Filling and sealing equipment.
(e) Weighing and measuring devices.
 An area of 10 square meters is recommended.
2.       Kajal and Surma
Equipment:
(a) Base sterilizer
(b)Powder sterilizer (dry heat oven)
(c) Stainless steel tanks
(d) A suitable Mixer
(e) Stainless steel sieves
(f) Filling and sealing arrangements
(g) Weighing and measuring devices
(h) Homogeniser (where necessary)
(i) Pestle and Mortar (for Surma).
An  area  of  10  square meters with  a  separate area  of  5  square meters for  base sterilization is recommended.
 Other requirements for 1 and 2:
(a) False ceiling shall be provided wherever required.
(b) Manufacturing area shall be made fly proof. An airlock or an aircurtain shall be provided.
(c) Base used for Kajal shall be sterilized by heating the base at 150 degree C for required time in a separate enclosed area.
(d) The vegetable carbon black powder shall be sterilized in a drying oven at 120 degree C for required time.
(e) All utensils used for manufacture shall be of stainless steel and shall be washed with detergent water, antiseptic liquid and again with distilled water.
(f) Containers employed for ‗Kajal‘ shall be cleaned properly with bactericidal solution and dried.
(g) Workers shall put on clean overalls and use hand gloves wherever necessary.

G. Aerosol.
Equipment:
(a) Air-compressor (wherever necessary).
(b) Mixing tanks.
(c) Suitable propellant filling and crimping equipments.
(d) Liquid filling unit.
(e) Leak testing equipment.
(f) Fire extinguisher (wherever necessary)
(g) Suitable filtration equipment.
(h) Weighing and measuring devices.

An area of 15 square meters is recommended.
Other requirements:  No  objection certificate  from the  Local  Fire  Brigade Authorities shall be furnished.

H. Alcoholic Fragrance Solutions.
Equipment:
(a) Mixing tanks with stirrer
(b) Filtering equipment
(c) Filling and sealing equipment
(d) Weighing and measuring devices.
An area of 15 square meters is recommended.

I. Hair Dyes.
Equipment:
(a) Stainless steel tanks
(b) Mixer
 (c) Filling Unit.
(d)Weighing and measuring devices.
(e)Masks, gloves and goggles
 An area of 15 square meters with proper exhaust is recommended.

J. Tooth powders and toothpastes, etc.:
1. Tooth-powder in General.
Equipment:
(a)Weighing and measuring devices.
(b)Dry mixer (powder blender)
(c) Stainless steel sieves.
(d) Powder filling and sealing equipments.
An area of 15 square meters with proper exhaust is recommended.
2. Toothpastes.
Equipment:
(a) Weighing and measuring devices.
(b) Kettle - steam, gas or electrically heated (where necessary)
(c) Planetary mixer with de-aerator system.
(d) Stainless steel tanks
(e) Tube filling equipment
(f) Crimping machine.
 An additional area of 15 square meters with proper exhaust is recommended.
3. Tooth-powder (Black)
Equipment:
(a) Weighing and measuring devices
(b)Dry mixer powder blender
(c) Stainless steel sieves
(d) Powder filling arrangements
 An  area  of  15  square  meters  with  proper  exhaust  is  recommended.  Areas  for manufacturing Black and White tooth powders should be separate

K. Toilet Soaps:
Equipment:
(a) Kettles/pans for saponification.
(b)Boiler or any other suitable heating arrangement
(c)Suitable stirring arrangement
(d) Storage tanks or trays
(e) Driers
(f) Amalgamator/chipping machine.
(g) Mixer
(h) Triple roller mill
(i) Granulator
(j) Plodder
(k) Cutter
(l) Pressing, stamping and embossing machine
(m)Weighing and measuring devices.
A minimum area of 100 square meters is recommended for the small-scale manufacture of toilet soaps.
The areas recommended above are for basic manufacturing of different categories of cosmetics. In addition to that separate adequate space for storage of raw materials, finished products, packing materials shall be provided in factory premises


For more detail refer Drug and Cosmetic Act

Comments

Contact Form

Name

Email *

Message *

Popular posts from this blog

What are the Schedules under Drug and Cosmetic Act, 1940 & Rules 1945?

State Pharmacy Council, Its Constitution and Composition and Functions

Pharmacy Council of India, Its Constitution and Composition and Functions