Systematic Diagram of Purified Water System
Wednesday, December 12, 2018
Tuesday, November 13, 2018
Basics and use of HVAC system in pharma
HVAC is an essential aspect in pharmaceutical industry as factors like temperature, relative humidity and ventilation have a direct impact on the quality of the pharmaceutical product. The designing of the HVAC should be sorted out while design concept of facility is in progress as it is linked to the architectural layouts like air locks, doorways and lobbies. Once the HVAC system is properly designed and installed it not only helps to create the required room pressure differential cascades but also prevents the cross contamination. Basically an HVAC system works by transferring the heat and moisture into and out of the air and controls the level of the air pollutant either by removing them or diluting them to a particular level.
TECHNOLOGY OVERVIEW:
HVAC system varies according to the size and installation capacity within a facility but the basic components remain almost the same.
LAYOUT OF A TYPICAL BASIC HVAC SYSTEM
HEATING SYSTEM:
The heat source is either a furnace or another popular choice is boilers that heat water for steam radiators, or forced-water systems with baseboard radiators, electric heat, and heat pumps. A furnace will generally operate on natural gas or propane, while a boiler will use gas or oil to heat the water. Furnaces are generally installed with central air conditioners. Heat pumps provide both heating and cooling. Some heating systems have an integrated water heating system. Another option is a hydronic heating system also called as radiant floor. These use piping under a floor, and are made up of flexible tubes that are filled with water or a glycol solution.
COOLING SYSTEM:
The purpose of cooling equipment is to chill the water for pumping to cooling coils. From one end the treated air is then blown over the chilled water coils into the space to be cooled through the ventilation system. As part of the refrigeration cycle in the chiller, heat must also be rejected from the system via a cooling tower or condenser.
DUCT LINES AND VENTILATION:
The ducts are used within the system to circulate both hot and chilled water in the building to the required areas. The stale air is expelled by using a separate duct line. The installation of duct lines is an important part therefore location and material type is considered at the time of designing of the HVAC system.
THERMOSTAT:
The thermostat (HVAC Controller) is installed to turn equipment on or off and to adjust the chillers and boilers, air and water flow rates, temperature and pressures. This also make the components work efficiently through the means of regulation of required conditions. A controller incorporating one or more temperature sensors inside the workspace sends a signal to the heating or cooling coils to activate.If there is a demand for heating or cooling then the controls may also send a signal to the chiller and boiler to operate as required. There are often other control panels on the chiller or boiler too, allowing users to have greater control.
TECHNOLOGY OVERVIEW:
HVAC system varies according to the size and installation capacity within a facility but the basic components remain almost the same.
LAYOUT OF A TYPICAL BASIC HVAC SYSTEM
HEATING SYSTEM:
The heat source is either a furnace or another popular choice is boilers that heat water for steam radiators, or forced-water systems with baseboard radiators, electric heat, and heat pumps. A furnace will generally operate on natural gas or propane, while a boiler will use gas or oil to heat the water. Furnaces are generally installed with central air conditioners. Heat pumps provide both heating and cooling. Some heating systems have an integrated water heating system. Another option is a hydronic heating system also called as radiant floor. These use piping under a floor, and are made up of flexible tubes that are filled with water or a glycol solution.
COOLING SYSTEM:
The purpose of cooling equipment is to chill the water for pumping to cooling coils. From one end the treated air is then blown over the chilled water coils into the space to be cooled through the ventilation system. As part of the refrigeration cycle in the chiller, heat must also be rejected from the system via a cooling tower or condenser.
DUCT LINES AND VENTILATION:
The ducts are used within the system to circulate both hot and chilled water in the building to the required areas. The stale air is expelled by using a separate duct line. The installation of duct lines is an important part therefore location and material type is considered at the time of designing of the HVAC system.
THERMOSTAT:
The thermostat (HVAC Controller) is installed to turn equipment on or off and to adjust the chillers and boilers, air and water flow rates, temperature and pressures. This also make the components work efficiently through the means of regulation of required conditions. A controller incorporating one or more temperature sensors inside the workspace sends a signal to the heating or cooling coils to activate.If there is a demand for heating or cooling then the controls may also send a signal to the chiller and boiler to operate as required. There are often other control panels on the chiller or boiler too, allowing users to have greater control.
Friday, November 2, 2018
Wednesday, October 24, 2018
Thursday, August 23, 2018
Monday, August 20, 2018
Types of granulation in tablet formulation
TYPES OF GRANULATION
Granulation can be achieved by three method as follows :-
1. Direct compression
Crystalline substance like sodium chloride, sodium bromide may be compressed directly. The vast majority of medicinal agents are rarely so easy to tablet, direct compression material should posses good flow and compresibility and must be inert, tasteless, able to disintegrate and inexpensive.
Method
(Drug + filler + disintegrant + lubricant + glidant ) all are blend directly after sifting through Viber sifter and compressed
2. Dry Granulation
It is used in situations where effective dose of a drug is too high for direct compaction and the drug is sensitive to heat, moisture, or both which preclude wet granulation. This is also called slugging method.
Method
A. (Drug + filler + lubricant) All are. blend then precompression done and after that comminution done
B. (glidant + lubricant + disintigrant) sizing then blend with A
3. Wet Granulation
Wet granulation forms the granules by binding the powders together with an adhesive, instead of by compaction. Liquid bridge are developed between particles, and the tensile strength of these bond increase as the amount of liquid binder added is increased. A drying process is required in all wet granulation to remove the solvent and to reduce the moisture content. After drying granulation is screened again, followed by compression.
Schematic drawing of All types granulation
Granulation can be achieved by three method as follows :-
1. Direct compression
Crystalline substance like sodium chloride, sodium bromide may be compressed directly. The vast majority of medicinal agents are rarely so easy to tablet, direct compression material should posses good flow and compresibility and must be inert, tasteless, able to disintegrate and inexpensive.
Method
(Drug + filler + disintegrant + lubricant + glidant ) all are blend directly after sifting through Viber sifter and compressed
2. Dry Granulation
It is used in situations where effective dose of a drug is too high for direct compaction and the drug is sensitive to heat, moisture, or both which preclude wet granulation. This is also called slugging method.
Method
A. (Drug + filler + lubricant) All are. blend then precompression done and after that comminution done
B. (glidant + lubricant + disintigrant) sizing then blend with A
3. Wet Granulation
Wet granulation forms the granules by binding the powders together with an adhesive, instead of by compaction. Liquid bridge are developed between particles, and the tensile strength of these bond increase as the amount of liquid binder added is increased. A drying process is required in all wet granulation to remove the solvent and to reduce the moisture content. After drying granulation is screened again, followed by compression.
Friday, August 17, 2018
THIN LAYER CHROMATOGRAPHY
THIN LAYER CHROMATOGRAPHY
Introduction
Thin layer chromatography (TLC) is a technique in which a solute undergoes distribution between two phases, a stationary phase, acting through adsorption and a mobile phase in the form of liquid.
The adsorbent is relatively thin, uniform layer of dry, finely powdered material applied to glass, plastic or metal sheet. Glass plates are most commonly used. Separation may also be achieved on the basis of partition or a combination of partition and adsorption, depending on a particular type of support, its preparation and its use with different solvent.
Identification can be effected by observation of spots of identical Rf value and about equal magnitude obtained respectively, with an unknown and reference sample chromatograph on the same plate.
Apparatus required
Flat glass plates of appropriate dimensions.
b) An aligning tray or plate surface on which the plates can be aligned and rested when coating substance is applied .
c) An adsorbant or coating substance consisting of finely divided adsorbant material, normally 5 µm to 40 µm in diameter. A variety of coating materials are available, but Silica gel is most frequently used. The adsorbent may contain fluorescing matter to help in visualizing spots that absorb ultraviolet light.
A spreader, which when moved over the glass plate, will apply a uniform layer of adsorbent, of a uniform thickness, usually between 150 to 250 µm.
A storage rack to support the plates during drying and transportation.
The apparatus described above are essentially required for the preparation of TLC plates. Ready to use TLC plates are commercially available, which may be used.
f) A developing chamber that can accommodate one or more plates and can be properly closed .
g) Graduated micro pipettes capable of delivering quantities.
h) A reagent sprayer that will emit a fine spray and will not itself be attacked by the reagent.
i) A viewing cabinet, fitted with ultra-violet light, suitable for observation at short (254 nm) and long (366 nm) ultra-violet wavelengths.
Precautions
The spot must be applied by holding the micro pipette as erect as possible, which avoids undue spreading of the spot and ensures a compact spot, usually 2 to 3 mm in diameter.
The syringes must be cleaned thoroughly, prior to spotting .
Use dedicated syringes, wherever feasible; especially for spotting impurities.
For developing solvents chromatographic grade solvents must be used, which avoids unwanted impurities being introduced on the plate.
All solutions for TLC including the mobile phase must be freshly prepared. TLC solvents may be kept separately to avoid accidental contamination.
If the mobile phase consists of more than two solvents, the solvents must be mixed in the order mentioned, keeping the volume recommended, as accurate as possible.
Unless unsaturated conditions are prescribed the developing chamber must be saturated with the developing solvent, prior to placing the TLC plates in the chamber.
h) The developing chamber is lined with sheet of filter paper which dips into the solvent in the base of the chamber which ensures complete saturation of the chamber with solvent vapour.
i) The developing chamber may be covered by a black cloth or Aluminum foil in case of spotting of light sensitive materials. The developing chamber must be placed on a firm surface, away from turbulence and use of acids; since these factors tend to spoil the plates. The developing chamber must be of good quality, having a flat bottom to ensure uniform flow of mobile phase.
Before and after spotting, the TLC plate must be inspected for any unwanted spots. The edges of the plate may be cut and rounded up for uniform movement of the mobile phase. The TLC plates must always be handled by holding at the edge, to avoid finger prints on the surface. The plates must be placed in an erect fashion in the developing chamber; which must always be covered.
Cutting of the pre-coated full plates into half plates or quarter plates, must be avoided as far as possible. It is a good practice to always use a full plate.
I) A narrow strip of coating substance, about 5 mm wide is usually removed from the vertical side of the TLC plate, to prevent accidental loss of the spot near the edge of the plate. In the case of ready to use plates, the narrow strip of coating substance is already removed.
m) The plates after preparation must be protected from moisture and used within three days of preparation. At the time of usage, the plates may be dried.
n) For drying of applied spots, during spotting a gentle current of air or nitrogen is used. Use of hot air from hair dryers must be avoided as the degradation of the spot, may be inadvertently introduced. The spotting must be carried out at least two cm from the bottom of the plate, to avoid direct contact with the mobile phase.
0) The spraying with reagent for development of the spot must be carried out uniformly over the plate. The spray must never be directed for a long time on a portion of the plate, as it results in localised darkening of the TLC plate.
p) The plates after spotting may be wrapped in Aluminium foil and than placed in a polybag for future reference. It is a good practice to calculate and record the Rf value of experimental spot and standard spot, during the identification test.
Quantitative evaluation -The identification of the raw material is deemed to be satisfactory, if the Rf value of the experimental spot and the standard spot is identical.
In case of degradation products which are denoted by secondary spots; these are compared with main spots of diluted samples (0.5, 1.0 or 2.0 %). These secondary spots are required to be not more intense than the main spot obtained from lower dilution of the parent compound. If more than one secondary spot is observed, the individual intensities of the secondary spots can be compared with the main spots of lower dilutions and can be added to get a rough idea of degradation products or related substances.
Advantages -
The technique is simple and less expensive.
It is one of the most important techniques used in stability indicating methods and gives ready information regarding degradation products.
It is useful technique for identification of the raw material, when compared to an authentic standard.
Disadvantages
The method is not quantitative.
In absence of availability of impurities for spotting, degradation products cannot be identified.
c) The precision and accuracy depends on the technique employed by an individual and hence can vary substantially from person to person.
Note :
Recent changes in the practice of TLC have, however resulted in improved performance both in terms of separation and quantitative measurements. These developments are referred to as High Performance Thin Layer Chromatography (HPTLC), which has combined HPLC techniques with TLC, to give quantitative measurements of high precision.
Monday, June 11, 2018
Wednesday, May 30, 2018
Polarimeter - introduction, Defination, apparatus and precautions for use in details
POLARIMETRY
Introduction
The electric fields associated with the beam of monochromatic light, vibrate in all directions perpendicular to the directions of propagation of light. Certain crystalline materials have different refractive indices for light, whose field vibrates parallel or perpendicular to the principal plane of the crystal. As a result, a Nicol prism constructed of this material transmits only light whose electric field oscillates in one plane. Optical activity concerns with the interaction of such plane polarised light with certain materials, particularly solutions of some organic compounds.
When a plane polarised light passes through a medium, it is retarded to an extent indicated by the refractive index of the medium. When the later is optically inactive, both circularly polarised components are retarded to the same extent and the beam emerges from the medium, polarised in the same plane as the incident beam. If the medium is optically active, the components are retarded to different extents and the beam emerges from the medium still plane polarised; but with the plane of polarisation inclined at an angle to the plane of polarisation of the incident beam. If the plane of polarisation is rotated clockwise, the substance is termed 'dextrorotatory', while if the plane of polarisation is rotated anticlockwise, the substance is termed 'laevorotatory'. Dextrorotation is designated (+) and laevorotation is designated (-).
Definitions
a) Optical Rotation : Optical rotation, unless otherwise specified, is measured at the wavelength of the 'D' line of Sodium (wavelength = 589.3 nm), at 25°C, on a layer 1 dm thick. It is expressed in degrees.
b) The specific optical rotation : The specific optical rotation of a liquid substance is the angle of rotation of the plane of polarisation at the wavelength of the 'D' line of Sodium, measured at 25°C unless otherwise specified, calculated with reference to a 1 dm thick layer of liquid and divided by the specific gravity of the liquid at 25°C.
The specific optical rotation of a solid substance is the angle of rotation of the plane of polarisation at the wavelength of the 'D' line of Sodium, measured at 25°C unless otherwise specified, calculated with reference to a 1 dm thick layer of a solution containing one gm of the substance per ml. The specific optical rotation of a solid is always expressed with reference to a given solvent and concentration.
Apparatus
The apparatus for measurement of rotation of a compound is known as the, Polarimeter.
It Consist of following parts
a) Light source -The source of light is usually Sodium vapour lamp, which emits monochromatic light.
b) Polariser - The polariser consists of a fixed Nicol prism at one end to convert ordinary light into plane polarised light.
c) Sample compartment -In this compartment the sample is placed in 1 dm or 2 dm tube. In the case of solids, a suitable solution is made, through which the plane polarised light is passed.
d) Analyser - The analyser consists of a movable Nicol prism, with a scale marked off in degrees. This is placed at the other end of the polarimeter.
e) Eye piece -The eye piece is placed at the analyser end.
Calibration -The polarimeter is calibrated using a solution of previously dried Sucrose and measuring the optical rotation in a 2 dm tube at 25°C for concentrations ranging from 10% w/v to 50% w/v.
The angle of rotation is as given in following table :
10.0 - 13.33°
20.0 - 26.61°
30.0. - 39.86°
40.0 - 53.06°
50.0. - 66.23°
Alternatively a quartz control plate with known optical activity can be used for calibration.
Precautions
The accuracy and precision of optical rotation measurements can be increased, if following precautions are taken
a) The instrument must be in a good condition. The optical elements must be very clean and in exact alignment.
b) Specific attention should be paid to the temperature control of the solution and the polarimeter.
c) Five consecutive readings are taken and the mean of these five readings is used for calculations to improve precision.
d) Polarimeter tube must be filled in such a way as to avoid air bubbles.
e) For tube with removable end plates fitted with gaskets and caps, the end plates must be tightened to ensure a leak proof seal between the end plate and the body of the tube.
f) For substances with low rotatory power, the end plates should be loosened and tightened again after each reading.
g) Spillage of the sample must be avoided.
h) The tube having the sample must be thoroughly cleaned. Liquid and solution of solids must be clear.
Introduction
The electric fields associated with the beam of monochromatic light, vibrate in all directions perpendicular to the directions of propagation of light. Certain crystalline materials have different refractive indices for light, whose field vibrates parallel or perpendicular to the principal plane of the crystal. As a result, a Nicol prism constructed of this material transmits only light whose electric field oscillates in one plane. Optical activity concerns with the interaction of such plane polarised light with certain materials, particularly solutions of some organic compounds.
When a plane polarised light passes through a medium, it is retarded to an extent indicated by the refractive index of the medium. When the later is optically inactive, both circularly polarised components are retarded to the same extent and the beam emerges from the medium, polarised in the same plane as the incident beam. If the medium is optically active, the components are retarded to different extents and the beam emerges from the medium still plane polarised; but with the plane of polarisation inclined at an angle to the plane of polarisation of the incident beam. If the plane of polarisation is rotated clockwise, the substance is termed 'dextrorotatory', while if the plane of polarisation is rotated anticlockwise, the substance is termed 'laevorotatory'. Dextrorotation is designated (+) and laevorotation is designated (-).
Definitions
a) Optical Rotation : Optical rotation, unless otherwise specified, is measured at the wavelength of the 'D' line of Sodium (wavelength = 589.3 nm), at 25°C, on a layer 1 dm thick. It is expressed in degrees.
b) The specific optical rotation : The specific optical rotation of a liquid substance is the angle of rotation of the plane of polarisation at the wavelength of the 'D' line of Sodium, measured at 25°C unless otherwise specified, calculated with reference to a 1 dm thick layer of liquid and divided by the specific gravity of the liquid at 25°C.
The specific optical rotation of a solid substance is the angle of rotation of the plane of polarisation at the wavelength of the 'D' line of Sodium, measured at 25°C unless otherwise specified, calculated with reference to a 1 dm thick layer of a solution containing one gm of the substance per ml. The specific optical rotation of a solid is always expressed with reference to a given solvent and concentration.
Apparatus
The apparatus for measurement of rotation of a compound is known as the, Polarimeter.
It Consist of following parts
a) Light source -The source of light is usually Sodium vapour lamp, which emits monochromatic light.
b) Polariser - The polariser consists of a fixed Nicol prism at one end to convert ordinary light into plane polarised light.
c) Sample compartment -In this compartment the sample is placed in 1 dm or 2 dm tube. In the case of solids, a suitable solution is made, through which the plane polarised light is passed.
d) Analyser - The analyser consists of a movable Nicol prism, with a scale marked off in degrees. This is placed at the other end of the polarimeter.
e) Eye piece -The eye piece is placed at the analyser end.
Calibration -The polarimeter is calibrated using a solution of previously dried Sucrose and measuring the optical rotation in a 2 dm tube at 25°C for concentrations ranging from 10% w/v to 50% w/v.
The angle of rotation is as given in following table :
Concentration. Angle of rotation
g /100ml. at 25°C10.0 - 13.33°
20.0 - 26.61°
30.0. - 39.86°
40.0 - 53.06°
50.0. - 66.23°
Alternatively a quartz control plate with known optical activity can be used for calibration.
Precautions
The accuracy and precision of optical rotation measurements can be increased, if following precautions are taken
a) The instrument must be in a good condition. The optical elements must be very clean and in exact alignment.
b) Specific attention should be paid to the temperature control of the solution and the polarimeter.
c) Five consecutive readings are taken and the mean of these five readings is used for calculations to improve precision.
d) Polarimeter tube must be filled in such a way as to avoid air bubbles.
e) For tube with removable end plates fitted with gaskets and caps, the end plates must be tightened to ensure a leak proof seal between the end plate and the body of the tube.
f) For substances with low rotatory power, the end plates should be loosened and tightened again after each reading.
g) Spillage of the sample must be avoided.
h) The tube having the sample must be thoroughly cleaned. Liquid and solution of solids must be clear.
Friday, May 25, 2018
Wednesday, May 16, 2018
Wednesday, March 14, 2018
Method of starch paste preparation for granulation tablet manufacturing
Material
Procedure
1. Take purified water in paste kettle and add surfactant and preservatives to it now
2. Heat the purified water to 100°C till boil
3. Dissolve starch in purified water in separate vessel and stirr till traslucent mass obtained
4. Add this translucent mass to hot purified water in paste kettle and stirr till it become slightly yellowish
- Starch
- Preservative - sodium methyl paraben, sodium propyl paraben etc.
- Binder - PVPK 30/40/60 , sugar, gelatin etc.
- Sufactant - sodium Lauryl sulphate etc.
Procedure
1. Take purified water in paste kettle and add surfactant and preservatives to it now
2. Heat the purified water to 100°C till boil
3. Dissolve starch in purified water in separate vessel and stirr till traslucent mass obtained
4. Add this translucent mass to hot purified water in paste kettle and stirr till it become slightly yellowish
Sunday, February 18, 2018
LIST OF SCHEDULES AS PER DRUGS AND COSMETIC ACT 1948
Indian pharmaceutical GMP guidelines are given in Drugs & Cosmetics Act 1940. Rules are given for pharmaceuticals and schedules are there to comply those rules.
MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health) updates this time to time. Pharmaceutical industries in India those are manufacturing the drug products for domestic market have to follow the Drugs & Cosmetics Act.
It contains 168 rules from 1 to 168 and 25 Schedules from Schedule A to Schedule Y.
Different type of forms are also given for different type of approvals from drug authorities.
Following are the schedules:
Schedule A: Forms and applications
Schedule B: Fees for test or analysis by the Central Drugs Laboratories or State Drugs Laboratories
Schedule C: Biological and Special Products
Schedule C(1): Other Special Products
Schedule D: Class of Drugs: Extent and conditions of exemption
Schedule D(I): Information and undertaking required to be submitted by the manufacturer of his authorized agent with the application form for a Registration Certificate. The format shall be properly filled in for each application in Form 40. The detailed information, secret in nature, may be furnished on a computer floppy.
Schedule D(II): Information required to be submitted by the manufacturer or his authorized agent with the application form for the registration of a bulk drug/formulation/special product for its import into India. The format shall be properly filled in and the detailed information, secret in nature, may be furnished on a computer floppy.
Schedule E: Omitted
Schedule E(1): List of Poisonous Substances under the Ayurvedic (including Siddha) and Unani Systems of Medicine
Schedule F: Part I to Part XII-A – Omitted
Part XII-B: Requirements for the functioning and operation of a Blood Bank and / or for preparation of Blood Components
(I) Blood Banks / Blood Components
(II) Blood Donation Camps
(III) Processing of Blood Components from whole blood by a Blood Bank
Part XII-C:
(I) Blood Banks / Blood Components
(II) Blood Donation Camps
(III) Processing of Blood Components from whole blood by a Blood Bank
Part XII-C:
(I) Requirements for manufacture of Blood Products
(II) Requirements for manufacture of Blood products from bulk finished products
Part XIII: General
Schedule F(I):
Part I: Vaccines
(A) Provisions applicable to the production of Bacterial Vaccines
(B) Provisions applicable to the production of Viral Vaccines
Part II: Antisera
Provisions applicable to the production of all sera from living animals
Part II: Diagnostic Antigens
Provisions applicable to the manufacture and standardization of Diagnostic Agents (Bacterial Origin)
Part IV: General
Schedule F(II): Standards for Surgical Dressings
Schedule F(III): Standards for umbilical Tapes
Schedule FF: Standards for Ophthalmic Preparations
Schedule G:
Schedule H: Prescription Drugs
Schedule G:
Schedule H: Prescription Drugs
Schedule I: Omitted
Schedule J: Disease and ailment (by whatever name described ) which a drug not purport to prevent or cure.
Schedule K: Class of drug: Extent and conditions of exemption
Schedule L1: Good Laboratory Practice
Schedule M: Good manufacturing practices and requirements of premises, plant and equipment for Pharmaceutical product.
Part I: Good manufacturing practices for premises and materials.
Part I-A: Specific requirements for manufacture of sterile products, parenteral preparation (small volume injectables and large volume parenterals ) and sterile ophthalmic preparation
Part I-B: Specific requirement for manufacturing of oral solid dosage forms (Tablet and Capsules).
Part I-C: Specific requirement for manufacture of oral liquids (Syrups, elixirs, emulsions and suspensions).
Part I-D: Specific requirements for manufacture of topical products i.e. external preparation (creams, ointments, pastes, emulsions, lotions, solutions, dusting powders and identical products)
Part I-E: Specific requirements for manufacture of metered-dose-inhalers (MDI)
Part I-F: Specific requirements of premises, plant and materials for manufacture of active pharmaceutical ingredients ( Bulk Drugs ).
Part II: Requirements of plant and equipment.
Schedule M-I: 1. Requirements of factory premises for manufacture of homoeopathic preparations.
2. Requirements of plants and equipments.
Schedule M-II: Requirements of factory premises for manufacture of cosmetic.
Schedule M-III: Requirements of factory premises for manufacture of medical devices.
Part I-B: Specific requirement for manufacturing of oral solid dosage forms (Tablet and Capsules).
Part I-C: Specific requirement for manufacture of oral liquids ( Syrup, elixirs, emulsions and suspensions).
Part I-D: Specific requirements for manufacture of topical products i.e. external preparation ( creams, ointments, pastes, emulsions, lotions, solutions, dusting powders and identical products )
Part I-E: Specific requirements for manufacture of metered-dose-inhalers (MDI)
Part I-F: Specific requirements of premises, plant and materials for manufacture of active pharmaceutical ingredients ( Bulk Drugs ).
Part II: Requirements of plant and equipment.
Schedule N: List of Minimum Equipment for the Efficient Running of a Pharmacy
Schedule O: Standard for Disinfectant Fluids
Schedule P: Life Period of Drugs
Schedule P1: Pack Sizes of Drugs
Schedule Q: List of Dyes, colours and Pigments permitted to be used in Cosmetics and Soaps as given under IS : 4707 (Part I)-1988 as amended by the Bureau of Indian Standards
Schedule R: Standards for condoms made of rubber latex intended for single use and other mechanical contraceptives
Schedule S: Standard for cosmetics.
Schedule T: Good manufacturing practices for Ayurvedic, Siddha and all Unani medicines.
Schedule U: I – Particulars to be shown in the manufacturing records.
II – Records of Raw Materials.
III – Particulars to be recorded in the analytical records.
Schedule U(I): I – Particulars to be shown in manufacturing records.
II – Records of Raw Material.
Schedule V: Standards for patent or proprietary medicines.
Schedule W: Omitted
Schedule X
Schedule Y: Requirements and guidelines for permission to import and/or manufacture of New Drug for sale or to undertake clinical Trials.
METHOD FOR PREPARATION OF LIPSTICK
Formulation and manufacturing of Lipstick
Lipstick:-
Lipstick is a cosmetic product containing pigments, oils, waxes, and emollients that apply color, texture, and protection to the lips.
Lipstick Raw Materials
Before making lipstick, ingredients must be chosen. The primary ingredients of every lipstick are waxes, oils, and pigments, but many other substances can be introduced into the mix that will enhance certain parts of the final product and add it some specific new features such as fragrance, longevity and gloss.
The wax used usually involves some combination of three types : beeswax, candelilla wax or the more expensive carnauba. Wax enables the mixture to be formed into the easily recognized shape of the cosmetic. Oils such as mineral, caster, lanolin, or vegetable are added to the wax.
Some of the most common secondary ingredients are preservatives (to ensure longer shelf life), alcohol (solvent for other substances), fragrance (oils and waxes can sometimes have their own smell and taste, which needs to be eliminated), antioxidant and others wide vaiety of other ingredients can also be included to make the substance smoother or glossy or to moisten the lips.
Lipstick tube
The tubes that hold lipstick range from inexpensive plastic dispensers for lip balms to ornate metal for lipsticks. Sizes are not uniform, but generally lipstick is sold in a tube 3 inches (7.6 cm) in length and about .50 inch (1.3 cm) in diameter. The tube has two parts, a cover and a base. The base is made up of two components, the twisting or sliding of which will push the lipstick up for application.
Description of Machinery in Lipstick Manufacturing
Lipstick Manufacturing Process
In general, wax and oil make up about 60% of the lipstick (by weight), with alcohol and pigment accounting for another 25% (by weight). Fragrance is always added to lipstick, but accounts for 1% or less of the mixture.
The most common lipstick manufacturing procedure is done in four stages.
PIC (Process in Control)
Air Bulb removing, There are many chances to crease air bulb within the paste during melting, mixing, and agitating.
The method of de-gas from the paste is set the paste without moving for certain time for enable the light weight air bulb floating up to the surface of paste form material.
Therefore, the bottom portion of the paste material will be applied as material to fill the lipstick molds. However, please care of the powder, color agent or particle sediment from the paste.
Quality Control in Lipstick Manufactruring
Lipstick product must meet FDA standards. Lipstick is the only cosmetic ingested, and because of this strict controls on ingredients, as well as the manufacturing processes, are imposed. Lipstick is mixed and processed in a controlled environment so it will be free of contamination. Incoming material is tested to ensure that it meets required specifications. Samples of every batch produced are saved and stored at room temperature for the life of the product to maintain a control on the batch.
Color control of lipstick is critical. The dispersion of the pigment is checked stringently when a new batch is manufactured, and the color must be carefully controlled when the lipstick mass is reheated. The color of the lipstick mass will bleed over time, and each time a batch is reheated, the color may be altered. Colorimetric equipment is used to provide some numerical way to control the shades of lipstick.
There are two special test for lipstick :
Lipstick:-
Lipstick is a cosmetic product containing pigments, oils, waxes, and emollients that apply color, texture, and protection to the lips.
Lipstick Raw Materials
Before making lipstick, ingredients must be chosen. The primary ingredients of every lipstick are waxes, oils, and pigments, but many other substances can be introduced into the mix that will enhance certain parts of the final product and add it some specific new features such as fragrance, longevity and gloss.
The wax used usually involves some combination of three types : beeswax, candelilla wax or the more expensive carnauba. Wax enables the mixture to be formed into the easily recognized shape of the cosmetic. Oils such as mineral, caster, lanolin, or vegetable are added to the wax.
Some of the most common secondary ingredients are preservatives (to ensure longer shelf life), alcohol (solvent for other substances), fragrance (oils and waxes can sometimes have their own smell and taste, which needs to be eliminated), antioxidant and others wide vaiety of other ingredients can also be included to make the substance smoother or glossy or to moisten the lips.
Lipstick tube
The tubes that hold lipstick range from inexpensive plastic dispensers for lip balms to ornate metal for lipsticks. Sizes are not uniform, but generally lipstick is sold in a tube 3 inches (7.6 cm) in length and about .50 inch (1.3 cm) in diameter. The tube has two parts, a cover and a base. The base is made up of two components, the twisting or sliding of which will push the lipstick up for application.
Description of Machinery in Lipstick Manufacturing
- Mixing Machine
- Seizing Machine
- Grinding Machine: Tri-Roller Rolling Machine and Successive High speed Moleculized Instrument – wet model
- Heating Mixing Machine for pearl ointment
- Mold Sets
- Filling Machine: Basic Type(conventional), Plate Type. Semi-Automatic Type, Fully Automatic Type
- Mold Releasing Machine By Air Blowing Machine
- Box Folding Machine
- Cartoning Machine
- Carton Tapping Machine
Lipstick Manufacturing Process
In general, wax and oil make up about 60% of the lipstick (by weight), with alcohol and pigment accounting for another 25% (by weight). Fragrance is always added to lipstick, but accounts for 1% or less of the mixture.
The most common lipstick manufacturing procedure is done in four stages.
- Pigment milling, in which you chose desired pigment, or the combination of pigment and then carefully mix them. Then, pigment is melt with oils or other fat good. The granule uniformity and particle distribution will be grinding by grinder to get optimization. The formula put through three-roll mill which grind ever particle usually to the size of 20 microns. Common ration of oil and pigment is 2 to 1 particles.
- Combination of pigment phase into base wax is done with simple mixing of those liquids in a steam-jacketed kettle that is equipped with one propeller agitator. After successful mixing, resulting liquid is again put through three-roll mill and usually grinded down to particle sizes of 20 microns. Perfume will be mixed within the paste phase under certain temperature and continuous agitating.
- Molding. Once the lipstick mass is mixed and free of air, it is ready to be poured into the tube. Molding is done at specific temperatures to eliminate certain unwanted products of fast cooling. Lipsticks liquid that is heated to around 80 C is poured into vertical split molds that are kept at temperature of around 35 C. To prevent formation of air bubbles in the molds, manufacturers often use slightly tilted molds or use vacuuming to forcefully extract any air. A variety of machine setups are used, depending on the equipment that the manufacturer has, but high volume batches are generally run through a melter that agitated the lipstick mass and maintains it as a liquid. For a smaller, manually run batches, the mass is maintained at the desired mix temperature, with agitation, in a melter controlled by an operator.
- Resulting lipstick is cooled down, extracted from the molds and prepared for flaming (passing of the sticks near one or several open flame torches or flaming cabinet that will meltsmall layer of gloss around lipsticks). This procedure will ensure better visual appearance of the lipstick, and protection from outside air and influences (lipsticks can become rancid after prolonged exposure to air, moisture and heat).
- Packaging and labeling is done with the requirements of the manufacturers of brand owner. After the lipstick is retracted and the tube is capped, the lipstick is ready for labeling and packaging. Labels identify the batch and are applied as part of the automated operation. There are a variety of packaging options available, ranging from bulk packs, and including packaging as a component in a makeup kit or special promotion offering. Packaging for lipstick varied, depending on what will happen at the point of sale in the retail outlet. Packaging may or may not be highly automated, and the package used depends on the end use of the product rather than on the manufacturing process.
PIC (Process in Control)
Air Bulb removing, There are many chances to crease air bulb within the paste during melting, mixing, and agitating.
The method of de-gas from the paste is set the paste without moving for certain time for enable the light weight air bulb floating up to the surface of paste form material.
Therefore, the bottom portion of the paste material will be applied as material to fill the lipstick molds. However, please care of the powder, color agent or particle sediment from the paste.
Quality Control in Lipstick Manufactruring
Lipstick product must meet FDA standards. Lipstick is the only cosmetic ingested, and because of this strict controls on ingredients, as well as the manufacturing processes, are imposed. Lipstick is mixed and processed in a controlled environment so it will be free of contamination. Incoming material is tested to ensure that it meets required specifications. Samples of every batch produced are saved and stored at room temperature for the life of the product to maintain a control on the batch.
Color control of lipstick is critical. The dispersion of the pigment is checked stringently when a new batch is manufactured, and the color must be carefully controlled when the lipstick mass is reheated. The color of the lipstick mass will bleed over time, and each time a batch is reheated, the color may be altered. Colorimetric equipment is used to provide some numerical way to control the shades of lipstick.
There are two special test for lipstick :
- The Heat Test. Lipstick is placed in the extended position in a holder and left in a constant temperature oven of over 130 degrees Fahrenheit (54 degrees Celsius) for 24 hours. There should be no dropping or distortion of the lipstick.
- The Rupture Test. Lipstick is place in two holders, in the extended position. Weight is added to the holder on the lipstick potion at 30-second intervals until the lipstick ruptures. The pressure required to rupture the lipstick is then checked against the manufacturer’s standards.
Friday, January 19, 2018
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