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Cosmetic Industry Compliance Overview

The cosmetic industry encompasses the manufacturing and distribution of various cosmetic products, regulated by laws such as the Drugs and Cosmetics Act of 1940 in India, which ensures safety and quality standards. Major companies dominate the market, generating significant revenue globally, while strict guidelines govern the import, manufacture, and sale of cosmetics. Compliance with good manufacturing practices, proper labeling, and environmental considerations are essential for maintaining product quality and safety.

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0% found this document useful (0 votes)
87 views34 pages

Cosmetic Industry Compliance Overview

The cosmetic industry encompasses the manufacturing and distribution of various cosmetic products, regulated by laws such as the Drugs and Cosmetics Act of 1940 in India, which ensures safety and quality standards. Major companies dominate the market, generating significant revenue globally, while strict guidelines govern the import, manufacture, and sale of cosmetics. Compliance with good manufacturing practices, proper labeling, and environmental considerations are essential for maintaining product quality and safety.

Uploaded by

shravani mane
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd

COSMETIC INDUSTRY

INTRODUCTION :
The cosmetic industry describes the industry that manufactures and
distributes cosmetic products. These include colour cosmetics, like foundation
and mascara, skincare such as moisturisers and cleansers, haircare such as
shampoos, conditioners and hair colours, and toiletries such as bubble bath
and soap. The manufacturing industry is dominated by a small number of
multinational corporations that originated in the early 20th century, but the
distribution and sale of cosmetics is spread among a wide range of different
businesses. Cosmetics must be safe when customers use them in accordance
with the label's instructions or in the conventional or expected manner. One
measure a producer may take to guarantee the safety of a cosmetic product is
product testing. FDA occasionally does testing as part of its research program
or when looking into potential safety issues with a product. Both the cosmetics
business and consumers can benefit from the FDA's resources on product
testing.
Cosmetics at department store Farmers Centre Place in Hamilton, New Zealand
The largest cosmetic companies are L'Oreal, Estée Lauder, Coty, Nivea, Shiseido
and Chanel.[1] The market volume of the cosmetics industry in Europe and the
United States is about EUR €70 billion per year, according to a 2005 publication.
[2] The worldwide cosmetics and perfume industry currently generates an
estimated annual turnover of US$170 billion (according to Eurostaf – May
2007). Europe is the leading market, representing approximately €63 billion[as
of?]."
DRUG AND COSMETIC ACT 1940 &1945
The Drugs and Cosmetics Act of 1940 is a law in India that regulates the import,
manufacture, distribution, and sale of drugs and cosmetics. The act's main
objectives are to ensure that drugs and cosmetics sold in India are safe,
effective, and meet state quality standards.

Here are some of the provisions of the Drugs and Cosmetics Act:
 Import and export:
The act ensures that only qualified personnel can import, manufacture,
distribute, and sell drugs and cosmetics. It also requires that cosmetics be
registered before being imported into the country.
 Quality:
The act requires that drugs and cosmetics meet state quality standards. It
also prohibits the production of counterfeit or substandard drugs and
cosmetics.
 Labeling and packaging:
The act prescribes how different types of drugs and cosmetics should be
labeled and packed.
 Inspections:
The act requires that drug inspectors regularly visit licensed premises.
 Sampling and analysis:
The act requires that samples of drugs and cosmetics be collected and
analyzed in accredited laboratories.
 The Drugs and Cosmetics Rules, 1945 provide guidelines for the storage,
sale, display, and prescription of drugs.
Prohibition of manufacture and sale or certain drugs and
cosmetics. –

From such date as may be fixed by the State Government by notification in


Official Gazette in this behalf, no person shall himself or by any other person on
his behalf-
(A) [(Note: manufacture for sale or for distribution, or sell, or stock or exhibit or
offer for sale, ] or distribute–
(i) Any drug which is not of a standard quality, or is misbranded, adulterated or
spurious;
(ii) Any cosmetic which is not of a standard quality or is misbranded or
spurious;
(iii) Any patent or proprietary medicine, unless there is displayed in the
prescribed manner on the label or container thereof the true formula or list of
active ingredients contained in it together with the quantities, thereof
(iv) Any drug which by means of any statement design or device accompanying
it or by any other means, purports or claims [(Note: Subs. by Act 11 of 1955,
sec.9, for "to cure or mitigate") to prevent, cure or mitigate] any such disease
or ailment, or to have any such other effect as may be prescribed
(v) Any cosmetic containing any ingredient, which may render it unsafe or
harmful for use under the directions, indicated or recommended;
(vi) Any drug or cosmetic in contravention of any of the provisions of this
Chapter or any rule made there under;
(B) Sell or stock or exhibit or offer for sale,] or distribute any drug [(Note: Ins.
by Act 11 of 1955, sec.14 (w.e.f. 27-7-1964)) or cosmetic] which has been
imported or manufactured in contravention of any of the provisions of this Act
or any rule made thereunder,
C) [(Note: Subs. by Act 68 of 1982, sec.14, for certain words (w.e.f. 1-2-1983))
manufacture for sale or for distribution, or sell, or stock or exhibit or offer for
sale,] or distribute any drug [(Note: Ins. by Act 21 of 1962, sec.14 (w.e.f. 27-7-
1964)) or cosmetic], except under, and in accordance with the conditions of
OFFENCE AND PENLTIES OF PROHIBITED DRUG AND COSMETIC
The Drugs and Cosmetics Act of 1940 prescribes various penalties for the
import, sale, and distribution of prohibited drugs and cosmetics, including:
Adulterated or spurious drugs and cosmetics :-
The penalty for importing adulterated or spurious drugs and cosmetics is up to
three years in prison and a fine of up to Rs 5,000.
Prohibited drugs and cosmetics
The penalty for importing other prohibited drugs and cosmetics is up to six
months in prison, a fine of up to Rs 500, or both.
Drugs and cosmetics in violation of notifications
The penalty for importing drugs and cosmetics in violation of notifications
issued under Section 10A is up to three years in prison or a fine of up to Rs
5,000.
Spurious drugs that cause grievous hurt or death
The penalty for manufacturing or selling spurious drugs that cause grievous
hurt or death is death.

CONDITION FOR OBTAINING LICENSE FOR IMPORT &


MANUFRACTURE OR SALE
Condition for obtaining licence for import and sale manufacturing in INDIA
To obtain a license for import and manufacturing in India, several conditions
and requirements must be met:
1] Business Registration: The entity must be legally registered in India (e.g., as
a private limited company, partnership, etc .
2] Import License: Obtain an Importer Exporter Code (IEC) from the Directorate
General of Foreign Trade (DGFT).
3] Manufacturing License: For certain products (like pharmaceuticals, food,
etc.), a specific manufacturing license from the relevant regulatory authority
(e.g., Drug Controller General of India for drugs) is required.
4]Compliance with Standards: Adherence to quality standards set by releva…
Environmental Clearance: For certain industries, environmental clearance may
be needed from the Ministry of Environment
5] Registration: Obtain Goods and Services Tax (GST) registration.
Documentation: Submit various documents such as business plan, financial
statements, identity proofs, and proof of premises.
Payment of Fees: Pay applicable fees for the licenses.
Inspection: Be prepared for inspections by regulatory authorities

DOCUMENTATION
Documentation refers to the collection of official papers and records that
provide evidence, information, or proof related to a particular process or or
activity. In the context of obtaining licenses for import and manufacturing,
documentation typically includes:"
BATCH FORMULA RECORD
"A Batch Formula Record (BFR) is a detailed document used in manufacturing
to specify the exact ingredients, quantities, and procedures required to
produce a specific batch of a product. It serves several key purposes:
Standardization: Ensures consistency in the manufacturing process.
Traceability: Allows tracking of ingredients and batches for quality control and
regulatory compliance.
Quality Assurance: Helps in maintaining product quality by following
established protocols.
Components of a Batch Formula Record
Product Information:
Product name:
Batch number:
Ingredients List:
Names and specifications of all raw materials
Manufacturing Instructions: Step by step procedure for production
Mixing or processing times and temperatures
Equipment Required: Specific machine or tools needed for
Quality Control Checks:
Parameters to be measured (e.g., pH, viscosity)
Testing methods and acceptance criteria
Packaging Instructions:
Type of packaging and labelling requirements
Documentation:
Sign-offs from relevant personnel (e.g., quality control, production managers)
Date and Batch Size:
Production date and total quantity procedure
MASTER FORMULA RECORD
"Master Formula Record (MFR) is a comprehensive document that outlines the
complete formulation and production process for a specific product. It serves
as a standardized reference for manufacturing and ensures consistency, quality,
and regulatory compliance.
Components of a Master Formula Record
Product Information:
Product name :
Product code or SKU:
Description of the product:
Formulation Details:
List of all ingredients, including specifications and sources:
Exact quantities for each ingredient:
Manufacturing Instructions:
Detailed step-by-step procedures for production
Equipment required (e.g., mixers, reactors)
Process Parameters:
Critical conditions (e.g., temperature, pressure, time)
Specific methods of mixing, heating, or cooling
Quality Control:
In-process checks and final product testing criteria
Sampling methods and acceptance standards
Packaging and Labelling:
Instructions for packaging materials and labelling requirements
Storage conditions for both raw materials and finished products
Batch Size:
Information on the intended batch size for production
QUALITY AUDIT REPORT

"A Quality Audit Report is a document that summarizes the findings of an audit
conducted to evaluate the quality management systems and processes within
an organization. It assesses compliance with standards, regulations, and
internal procedures, providing insights into areas of strength and opportunities
for improvement.
Components of a Quality Audit Report
Audit Overview:
Purpose of the audit
Scope and objectives
Date and location of the audit
Audit team members
Executive Summary:
Description of the audit approach (e.g., document review, interviews,
observations)
Standards and criteria used for evaluation
Findings:
Detailed observations organized by area or department
Compliance issues, non-conformities, and areas of improvement
Evidence supporting each finding (e.g., data, documents)
A Quality Audit Report is crucial for maintaining high standards of quality and
fostering a culture of continuous improvement within an organization. Action
Plan:
Proposed timelines and responsibilities for implementing recommendations
Importance
Compliance: Helps ensure adherence to regulatory standards and internal
policies
DISTRIBUTION RECORD
" Distribution Report is a document that provides an overview of the
distribution activities of a company, detailing the movement of goods from the
manufacturer or supplier to the end customer. It is essential for evaluating the
efficiency and effectiveness of distribution operations.
Components of a Distribution Report
Report Overview:
Title and date of the report
Period covered by the report
Executive Summary:
Major achievements or challenges faced during the reporting period
Distribution Metrics:
Total volume of goods distributed
Number of orders fulfilled
Delivery timelines and on-time performance rate .
Inventory Levels:
Current stock levels at various distribution points
Inventory turnover rates
Shipping Details:
Modes of transportation used (e.g., truck, air, sea)
Shipping costs and comparisons to budget
Geographic Distribution:
Breakdown of distribution by region or location
Analysis of sales patterns in different areas
Customer Feedback:
Summary of customer satisfaction related to distribution
HANDLING RETURN GOOD

Establish a Return Policy: Clearly define the conditions under which returns
are accepted, including time limits, acceptable reasons, and the state of the
goods.
Create a Return Process: Set up an easy process for customers to initiate
returns. This can include online forms, return labels, or designated return
locations.
Inspect Returned Items: Upon receipt, thoroughly inspect returned goods for
damage, missing parts, or signs of use to determine if they can be restocked or
need to be returned to the supplier.
Restock or Dispose: Decide whether items can be resold, repaired, or need to
be discarded. Ensure that restocked items are in sellable condition.
Update Inventory: Adjust inventory records to reflect returns accurately to
maintain stock levels.
Customer Communication: Keep customers informed about the return process,
status, and any refunds or exchanges.
Recycling and waste disposal of cosmetics require carefully handling due to the
potentional environmental impact .
Recycling
Check for Recycling Symbols: Look for recycling symbols on packaging. Many
containers can be recycled if they are clean and dry.
Separate Components: Remove pumps, lids, and labels, as they may not be
recyclable. Rinse containers to eliminate residue.
Utilize Take-Back Programs: Some brands offer take-back programs for their
products, allowing customers to return used containers for recycling.
Use Refillable Options: Choose brands that offer refillable containers to reduce
waste.
WASTE DISPOSAL MANAGEMENT
Follow Local Regulations: Research local guidelines for disposing of cosmetics,
as regulations can vary by location.
Avoid Flushing: Never flush cosmetics down the toilet, as they can pollute
water sources.
Dispose of Hazardous Materials Properly: Items like nail polish remover and
certain skincare products may require special disposal methods. Check for
hazardous waste collection sites.
Compost Natural Ingredients: If products contain organic ingredients, they may
be composted, though check for any packaging that might not be compostable.
Educate Consumers: Inform customers about proper disposal methods to
promote environmental responsibility.

"The vendor evaluation process is critical for ensuring that suppliers meet
your organization’s needs and standards. Here’s a structured approach:

1. Define Requirements
Identify Needs: Outline what products or services you require.
Set Criteria: Establish evaluation criteria, such as quality, cost, reliability, and
delivery timelines.
2. Research Potential Vendors
Market Analysis: Identify potential vendors through industry research, referrals,
and online directories.
Request Information: Gather initial information about their offerings,
reputation, and capabilities.
3. Develop a Request for Proposal (RFP)
Create RFP Document: Include specifications, evaluation criteria, deadlines,
and terms of engagement.
Distribute RFP: Send the RFP to selected vendors.
Cosmetic product labels typically list ingredients in the following
categories:
Common Ingredient Categories
Water (Aqua): Often the primary ingredient in many formulations.
Emollients: Ingredients like oils (e.g., jojoba oil, shea butter) that provide
moisture.
Humectants: Substances like glycerin and hyaluronic acid that attract moisture
to the skin.
Surfactants: Ingredients such as sodium lauryl sulfate used for cleansing and
foaming.
Preservatives: Compounds like parabens and phenoxyethanol that prevent
microbial growth.
Fragrance/Parfum: Added for scent, which can sometimes cause sensitivity.
Colorants: Dyes and pigments used to enhance appearance (e.g., titanium
dioxide, mica).
Thickeners: Ingredients like xanthan gum that adjust product consistency.
Active Ingredients: Specific compounds for targeted effects (e.g., salicylic acid
for acne).
Botanical Extracts: Plant-derived ingredients (e.g., aloe vera, chamomile
extract) that offer benefits.
Regulatory Considerations
INCI Naming: Ingredients are typically listed using their International
Nomenclature of Cosmetic Ingredients (INCI) names.
Descending Order: Ingredients are listed in descending order of concentration,
with the most prevalent listed first.
Important Notes
Allergens: Products must indicate common allergens (e.g., nuts, gluten) when
applicable.
Claims: Labels may include claims (e.g., “hypoallergenic,” “non-comedogenic”)
but should be verified against ingredient safety.
GOOD MANUFRACTURE PRACTICES
"Current Good Manufacturing Practices (cGMP) are essential guidelines that
ensure the quality and safety of products in industries such as pharmaceuticals,
cosmetics, and food. Here are the key principles of cGMP:
1. Quality Management
Establish a robust quality management system to oversee all manufacturing
processes.
2. Personnel Training
Ensure all employees are trained and qualified for their roles, understanding
cGMP requirements and safety protocols.
3. Facility and Equipment
Maintain clean, organized, and suitable facilities and equipment to prevent
contamination.
Regularly inspect and maintain equipment to ensure proper functioning.
4. Standard Operating Procedures (SOPs)
Develop and follow documented SOPs for all processes, including production,
quality control, and sanitation.
5. Raw Material Control
Implement strict controls for the selection, testing, and storage of raw
materials to ensure quality.
6. Production Processes
Follow validated processes to ensure consistency and reproducibility.
Monitor critical parameters and keep detailed records of production activities.
7. Quality Control
Establish a quality control system to test and validate products at various stages
of production.
Conduct regular audits and inspections to identify and address non-
compliance.
"The International Council for Harmonisation (ICH) provides guidelines for
stability studies to ensure the quality and safety of pharmaceutical products.
Here’s an overview of the key ICH guidelines related to stability studies”
1. ICH Q1A (Stability Testing of New Drug Substances and Products)
Objective: Establishes the framework for stability testing to ensure that
products remain safe and effective over their shelf life.
Stability testing should include long-term, intermediate, and accelerated
studies.
Environmental conditions for testing (temperature, humidity) must be
specified.
Testing should focus on physical, chemical, biological, and microbiological
characteristics.
2. ICH Q1B (Stability Testing: Photostability Testing of New Drug Substances
and Products)
Objective: Addresses the need for photostability testing to evaluate the effects
of light on drug substances and products
Establish a photostability testing protocol, including the type of light exposure.
Compare results with those from stability studies under standard conditions.
3. ICH Q1C (Stability Testing for New Dosage Forms)
Objective: Provides guidelines for stability testing of new dosage forms,
including formulations that differ from previously approved products.
Stability studies should consider the characteristics of the new dosage form
and its intended use.
Includes recommendations for long-term and accelerated stability testing.
4. ICH Q1D (Stability Testing for Applications for Variations)
Objective: Outlines stability requirements for variations in approved products,
such as changes in formulation or manufacturing process
Evaluate the impact of the variation on product stability.
Define appropriate stability study designs based on the nature of the changes.

5. ICH Q1E (Stability Data Package for Registration Applications)


Objective: Provides guidance on the data package required for registration
applications regarding stability.
Key Points:
Requires a comprehensive stability data package to support shelf life claims.
Emphasizes the importance of long-term data in establishing a product's shelf
life.
Key Considerations for Stability Studies
Testing Conditions: Define and maintain specific temperature and humidity
levels based on ICH recommendations.
Data Analysis: Use statistical methods to analyse stability data and determine
shelf life.
Reporting: Ensure clear documentation and reporting of study results,
including any deviations and their implications.
By following these guidelines, companies can ensure that their pharmaceutical
products maintain their quality and safety throughout their intended shelf life.

Skin :
Common Skin Problems:
Acne: Caused by clogged pores, excess oil, and bacteria, leading to
inflammation and breakouts.
Eczema: A chronic condition characterized by itchy, inflamed skin; often
triggered by allergens or irritants.
Psoriasis: An autoimmune condition leading to rapid skin cell turnover,
resulting in red, scaly patches.
Dermatitis: Inflammation of the skin due to contact with irritants or allergens.
Prevention and Treatment:
Hygiene: Regular cleansing and moisturizing to maintain skin barrier function.
Topical Treatments: Use of corticosteroids for inflammation, retinoids for acne,
and emollients for eczema.

Oral Cavity :
Common Oral Problems:
Cavities (Dental Caries): Decay caused by plaque buildup and acid from
bacteria that erodes tooth enamel.
Gingivitis: Inflammation of the gums due to plaque accumulation, leading to
redness and swelling.
Oral Thrush: A fungal infection caused by Candida, resulting in white patches in
the mouth.
Bad Breath (Halitosis): Often caused by poor oral hygiene, dry mouth, or
dietary factors.

Prevention and Treatment:


Oral Hygiene: Regular brushing and flossing to remove plaque and food
particles.
Regular Dental Visits: Professional cleanings and check-ups to detect issues
early .
Fluoride Treatments: Strengthening tooth enamel to prevent cavities.

Hair :
Common Hair Problems:
Hair Loss (Alopecia): Can be due to genetic factors, hormonal changes, stress,
or medical conditions.
Dandruff: Flaky, itchy scalp often caused by dry skin or seborrheic dermatitis.
Dry and Brittle Hair: Caused by environmental factors, over-styling, or lack of
moisture.
Scalp Conditions: Such as psoriasis or fungal infections.
Prevention and Treatment :
Gentle Hair Care: Use of mild shampoos and conditioners; avoid excessive heat
and harsh treatments.
Nutrition: A balanced diet rich in vitamins and minerals (e.g., biotin, zinc) to
support hair health.
Consultation: Seek professional advice for persistent issues, particularly for hair
loss.
Cavity-Related Problems
Root Canals: Treatment for infected or damaged tooth pulp, often required
after severe decay.
Dental Abscess: A localized infection in the tooth or gums leading to pain and
swelling.
Sensitivity: Tooth sensitivity to hot, cold, or sweet substances, often caused by
enamel erosion or gum recession.

1. Face Care:
Cleansing: Use a gentle facial cleanser suited to your skin type (gel for oily skin,
cream for dry skin).
Exfoliation: Exfoliate 1-2 times a week to remove dead skin cells, using
chemical (AHAs/BHAs) or physical exfoliants.
Moisturizing : Follow cleansing with a suitable moisturizer to hydrate the skin.
Sun Protection: Apply sunscreen daily to protect against UV damage.

2. Gum Care:
Brushing: Brush teeth at least twice a day using fluoride toothpaste and a soft-
bristled toothbrush.
Flossing: Floss daily to remove plaque and food particles between teeth and
along the gum line.
Mouthwash: Use an antibacterial mouthwash to help reduce plaque and
freshen breath.
Regular Dental Visits : Schedule dental check-ups every six months for
professional cleanings and assessments.

3. Nail Care:
Cleaning: Wash hands regularly and clean under nails with a brush.
Trimming: Trim nails regularly to prevent breakage and hangnails.
Moisturizing: Use hand cream and cuticle oil to keep nails and surrounding skin
hydrated.

4. Scalp Care:
Shampooing : Wash hair with a suitable shampoo to remove dirt and excess
oil, adjusting frequency based on hair type.
Conditioning : Use a conditioner to nourish hair and maintain scalp health.
Scalp Massage : Gently massage the scalp to improve circulation and promote
relaxation.
Avoid Product Buildup : Use clarifying shampoos periodically to remove
buildup from hair products.

5. Body Care:
Cleansing : Use a gentle body wash or soap to cleanse the skin during showers
or baths.
Exfoliation : Exfoliate the body 1-2 times a week using a scrub or loofah.
Moisturizing : Apply body lotion or cream to keep skin hydrated, especially
after bathing.
Underarm Care
Cleansing: Clean underarms daily with soap and water to remove sweat and
bacteria.
Deodorant : Use a deodorant or antiperspirant to control odour and moisture.

"Formulating personal care products for Moisturizing Cream, vanishing


cream , Cold Cream, Cleansing Cream, Saving cream ,Shampoo, Perfume
Aerosole ,Oientment, Lotion ,Tablet ,Capsule , Foot Care Product “

1. Moisturizing Cream:
Skin Type Consideration :
Dry Skin: Include occlusive agents (e.g., shea butter, cocoa butter) for long-
lasting hydration.
Oily Skin: Use lightweight, non-comedogenic oils (e.g., jojoba oil) and gel-based
formulations.
Active Ingredients: Incorporate humectants like glycerin or hyaluronic acid for
moisture retention.
Cultural Preferences: Consider fragrance preferences and any local natural
ingredients (e.g., coconut oil, aloe vera).

2. Vanishing Cream:
Texture: Aim for a lightweight, non-greasy texture that absorbs quickly.
Emulsifiers: Use effective emulsifiers to ensure a smooth consistency (e.g.,
glyceryl stearate).
Ingredients: Include skin-soothing ingredients like allantoin or calendula
extract, which are often preferred for sensitive skin types.
Skin Tone Adaptation: Consider formulations that enhance or match skin tones
(e.g., tinted options).
3. Cleansing Cream:
Gentleness: Formulate with mild surfactants to avoid stripping natural oils.
Look for sulphate-free options.
Hydration: Incorporate moisturizing agents to prevent dryness (e.g., glycerin,
aloe vera).
Natural Extracts: Use botanical extracts that resonate with cultural preferences
(e.g., green tea, chamomile).
pH Balance: Ensure the formula maintains a skin-friendly Ph

4. Shaving Cream:
Lubrication: Use emollients like glycerin and fatty acids to provide a smooth
glide.
Skin Sensitivity : Incorporate soothing agents (e.g., aloe, chamomile) to
minimize irritation.
Foam Stability : If creating a foaming cream, ensure stability and consistency in
performance.
Fragrance : Consider fragrance preferences based on cultural norms; some may
prefer unscented options.

5. Shampoo :
Hair Type Consideration:
Curly/Kinky Hair : Include moisturizing ingredients (e.g., shea butter, oils) and
sulphate-free surfactants to prevent dryness.
Straight/Wavy Hair : Lighter formulations with less oil might be preferred.
Scalp Health : Add ingredients that promote scalp health, like tea tree oil or
salicylic acid for oily scalps.
Cultural Ingredients : Integrate locally favored ingredients (e.g., hibiscus,
coconut) for cultural resonance.

6. Perfume
Fragrance Notes : Understand preferred fragrance families (floral, woody,
citrus) within different cultures.
Longevity and Sillage : Formulate for desired wear time and fragrance
projection, adjusting oil concentration accordingly.
Skin Interaction : Consider how different skin types might alter fragrance
perception; offer layering suggestions (e.g., matching body lotions).
Cultural Sensitivity : Be aware of any cultural restrictions on fragrance use and
adjust formulations accordingly.
Tablet Punching Machine :
Tablet compression machines are a
fundamental component in
pharmaceutical manufacturing,
essential for transforming granulated
powder into tablets and pills. These
machines utilize precise mechanical
processes to ensure the uniformity and
quality of the produced tablets, which
are crucial for effective medication. This
article delves into the working
principles, types, components, and
operation of tablet compression
machines, providing a comprehensive understanding of their function in the
pharmaceutical industry.
Key Components of Tablet Compression Machines
Tablet compression machines consist of several critical components:
Hopper: This is where the granulated powder is fed into the machine.
Die: A cavity that determines the size and shape of the tablet.
Punches: Upper and lower punches compress the powder within the die cavity.
Turret: Holds multiple sets of punches and dies and rotates to facilitate
continuous compression.
Cam Tracks: Guide the punches through their respective movements.
Feeder System: Ensures a consistent flow of powder into the die cavity.
Pressure Rollers: Apply the necessary force to compress the powder into
tablets.
Discharge Chute: Ejects the formed tablets out of the machine.
Capsule Filling Machine :
The capsule filling machine, simply
called the capsule filler, is equipment
utilized to fill empty capsules with
pharmaceutical ingredients. These
capsule-filling machines can be
classified into two categories according
to their uses and functions: professional
capsule-filling machines and personal
capsule-filling machine.

The professional capsule-filling machine


is used in the pharmaceutical industry for large-scale production and higher
efficiency. These are primarily automatic filler machines that fill a set amount
of medication or pharmaceutical ingredients into the capsule.

Whereas the personal capsule filling machine is utilized for small-scale capsule
production. Such capsule fillers allow the individual or a small business to fill
the capsule with the necessary prescribed medication when required.

Capsule Filling Machine Working Principle:


Every capsule filler has its unique working principle. The step-by-step working
process of the capsule filling machine is as follows:
 Positioning of translucent and colorless capsules in the capsule filling
tray.
 Removing the capsule caps from the body
 Filling the capsule body with prescribed pharmaceutical ingredients
 Rearranging the capsule caps onto the capsule body
 Expulsion of the filled capsules from the machine
Freeze Dryer :
A freeze dryer works in three phases:
Freezing
Primary Drying (Sublimation)
Secondary Drying (Adsorption)
Proper freeze drying can reduce drying
times by 30%.

Phase 1: Freezing Phase


Graph showing how a freeze dryer works and what is the ideal freeze drying
pressure and freeze drying temperature. This is the most critical phase. Freeze
dryers use various methods to freeze a product. Freezing can be done in a
freezer, a chilled bath (shell freezer), or on a shelf in the freeze dryer. The
freeze dryer cools the material below its triple point to ensure that
sublimation, rather than melting, will occur. This preserves the material’s
physical form.
Phase 2: Primary Drying (Sublimation)
The second phase is primary drying (sublimation), in which the pressure is
lowered and heat is added to the material in order for the water to sublimate.
The freeze dryer’s vacuum speeds sublimation. The freeze dryer’s cold
condenser provides a surface for the water vapor to adhere and solidify. The
condenser also protects the vacuum pump from the water vapor. About 95% of
the water in the material is removed in this phase. Primary drying can be a
slow process. Too much heat can alter the structure of the material.
Phase 3: Secondary Drying (Adsorption)
This final phase is secondary drying (adsorption), during which the ionically-
bound water molecules are removed. By raising the temperature higher than in
the primary drying phase, the bonds are broken between the material and the
water molecules.Freeze dried materials retain a porous structure.After the
freeze dryer completes its process, the vacuum can be broken with an inert gas
before the material is sealed.Most materials can be dried to 1-5% residual
moisture.
Brookfield Viscometer :
Brookfield viscometers are a
type of rotational viscometer
that measure the viscosity of
liquids and semi-solids. They
are widely used in labs globally
and are considered an industry
standard. Here is some
information about Brookfield
viscometers:
How they work: A calibrated
spring applies torque to a
spindle immersed in a fluid, and the spring deflection measures the fluid's
viscosity.
What they can measure: Brookfield viscometers can measure the viscosity of
Newtonian fluids, such as water and thin motor oils, and non-Newtonian fluids.
Features: Brookfield viscometers can have features such as:
 Direct display of viscosity, torque, spindle, and speed
 Torque measurement accuracy of 1% of full scale range
 Repeatability of 0.2% of full scale range
 Compatibility with all Brookfield accessories
Maintenance: Brookfield recommends annual calibration and repair service by
Brookfield or an authorized dealer to ensure optimal performance.
Sample preparation: Before measuring, samples should be free of air bubbles,
at a uniform temperature, and properly homogenized.
Temperature: Thermostatic baths can be used to maintain the desired
temperature.
Viscosity standards: NIST traceable viscosity standards are available.
PREPARATION AND EVALUATION OF HERBAL SHAMPOO
FORMULATION OF HERBAL SHAMPOO –
 To the gelatin solution (10%), added the herbal extract and mixed by
shaking continuously at the time interval of 20 min. 1 ml of lemon juice
was also added with constant stirring.
 To improve aroma in the formulation, sufficient quantity of essential oil
(rose oil) was added and made up the volume to 100 ml with gelatin.
EVALUATION OF HERBAL SHAMPOO –
 The prepared formulation was evaluated for product performance which
includes organoleptic characters, pH, physicochemical characterization,
and for solid content.
 To guarantee the nature of the items, particular tests were performed
for surface tension, foam volume, foam stability, and wetting time using
standard protocol.
Visual assessment –
The prepared formulation was assessed for color, clarity, odor, and froth
content.
pH determination –
The pH of the prepared herbal shampoo in distilled water (10% v/v) was
evaluated by means of pH analyzer at room temperature .
Surface tension measurement –
The prepared shampoo in distilled water (10% w/v) was evaluated for surface
tension using stalagmometer in room temperature .
Testing of wetting –
Wetting time was calculated by noting the time required by the canvas paper to
sink completely [3]. A canvas paper weighing 0.44 g was cut into a disc of
diameter measuring 1-inch. Over the shampoo (1% v/v) surface, the canvas
paper disc was kept and the time taken for the paper to sink was measured
using the stopwatch.
Foam stability test –
The stability of the foam was determined using cylinder shake method. About
50 ml of formulated shampoo (1%) solution was taken in a graduated cylinder
of 250 ml capacity and shaken for 10 times vigorously. Foam stability was
measured by recording the foam volume of shake test after 1 min and 4 min,
respectively . The total foam volume was measured after 1 min of shaking.
Dirt dispersion test –
To 10 ml of refined water two drops of cleanser were included and taken in a
wide-mouthed test tube. To the formulated shampoo, added one drop of
Indian ink and shaken for 10 min after closing the test tube with a stopper. The
volume of ink in the froth was measured and the result was graded in terms of
none, slight, medium, or heavy.

PHYSICOCHEMICAL PROPERTIES OF HEARBAL SHAMPOO –

Evaluation test Formulated shampoo

Color Brown

Transparency Clear

Odor Good

pH of 10% solution 7

Solid contents (%) 23.25

Foam volume (ml) 25

Foam type dense small


Surface tension (dynes/cm) 35.18

Wetting time (s) 120 s


REFERENCE :
1. https://ijcrt.org/papers/IJCRT2009364.pdf
2. https://www.ijpbs.com/view.php?iid=2365
3. https://www.ijpbs.com/view.php?iid=2365

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