Classification of Pharma Industry

Active Pharmaceutical Ingredients (API) Formulations

Parental Bio Pharma

Pharmaceuticals companies should follow GMP

 Good Manufacturing Practice (GMP)

The Good Manufacturing Practice (GMP) principles help ensure quality of manufactured
product throughout the manufacturing, processing and packaging stages. They are used to
make sure that the products are safe, pure, and effective. GMP principles address a wide
range of issues as varied as record keeping, personnel qualifications, sanitation, cleanliness,
equipment verification, process validation, and complaint handling.

Why GMP?: Poor quality medicines are a health hazard. Medicines produced as per GMP
standards are safe and have the intended therapeutic effect.

ULTIMATE GOAL “QUALITY & PATIENTS SAFETY”

Basic requirements of GMP

 Basic requirements of GMP

• Manufacturing process
• Sanitation and Hygiene
• Garments
• Water treatment system
• Equipment & their calibration
• Environment monitoring / Air handling system
• Sterilisation
• Clean room
• Documentation
Types of Contamination

Microbiological Contamination Fungal Contamination

Effects
Batch Failure

Skin absorption of harmful substances –

Solvents, Harmful dusts, Pesticides,
insecticides, fertilizers
Chemical burns
Thermal burns
Cold burns
Respiratory problems
Physical problems

Products needed to fulfil GMP requirement.

• When our skin is broken these substances are more likely to penetrate this barrier and
enter our bodies.
• Almost every type of solvent can be absorbed into the skin. Some solvents may cause
itching, rashes, or swelling. Other solvents can actually penetrate the skin and get
directly into your bloodstream. These solvents can cause damage to internal organs.
• Exposure to harmful dusts causes skin irritation, which can result in dermatitis or skin
rashes.
• They may impact us after only one use or they may require years of use before we see
symptoms of exposure.
• Make sure you know what substances in your facility can harm your skin and hands

Glove Need Arises Here

 Glove Materials
•Vinyl (poly vinyl chloride)
•Polyurethane
•Natural Rubber Latex (powdered or non)
•Neoprene (chlorinated)
•Nitrile

Selecting Disposable Gloves

– Protection against blood borne pathogens
– Latex allergy or sensitivity
– Nitrile gloves comparable to latex
– Protection against some chemicals
– Easily rip, tear, puncture
– Correct size
 ASTM D 5151 ASTM D 6124
Tested for detection of Holes in Tested for Residual Powder
Gloves in Gloves
 Natural rubber latex for tactile sensitivity and comfort
All our manufactured gloves are from double centrifuged latex. ASTM D 5712 ASTM D 3577
 Made from FDA approved pigment Tested for Analysis of Aqueous Tested for Standard
 Optimized for pharmaceutical manufacturing Extractable Protein specification of Rubber
Gloves
 Ambidextrous / Anatomical designed
 Low Protein
 AQL 1.5 – global standard for low pinhole incidence EN 455-2 ISO13485
 Micro rough surface / Textured finish Tested for physical properties of Tested for approval process
gloves for the IVD and MDD
 Polymer coated for easy donning and Beaded cuff for Directives
added strength / easy donning

Chlorination is a process wherein Gloves are exposed to Chlorine gas which is environmentally hazardous and also for the
person exposed to it. This process is out-dated and majority of the hospitals and doctors are banned chlorinated gloves.

Gloves with unique blend of Polymer provide excellent dry and damp hand donning capabilities. Polymer Coating is the
advanced and most modern technology widely used. Polymer coated gloves is more convenient way to wear a glove
because it creates a complete coating on the inner surface of the glove and therefore reduces latex sensitivities and
allergies.
Latex Gloves
• Pre Powdered & Powder Free,
• Examination (Ambidextrous) / Surgical (Anatomically Shaped)
• Chlorinated / Polymer coated
• Sterile (ETO Sterile / Gamma Sterile) / Non Sterile
• Available Length: 10”, 12”, 16” & 18”
• Available Palm size: 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9 / S,M,L

Product Description
Quality Standards
 Low protein and undetectable chemical residue to minimize hypersensities
 Bio-Degradable  Manufactured under GMP, EN ISO 13485:2016
and ISO 9001:2015 quality management system
 Eco Friendly medical grade paper
 Conforms to ASTM D 3577, EN455, IS13422 and
 Gloves compounded primarily from natural rubber latex (type-1) – ISO 10282 standards
 Free from dirt marks, oil stains, embedded foreign particles, coagulam etc.  Bio-burden and sterility complies as per
regulatory requirements
 Sterile gloves for single use only.
 Hypoallergenic reducing potential allergic
 Micro rough surface in palm and finger area reactions
 Keep the gloves in cool, dry place and away from direct sun light  Factory standard of AQL 1.5 for pinholes
Nitrile Gloves
NITRILE Exam Gloves are the glove for outstanding barrier protection from bacteria, viruses and chemicals.
PURPLE NITRILE Exam Gloves offer the highest level of chemotherapy protection. These durable gloves are
available in 9.5- and 12-inch lengths. NITRILE Exam Gloves are especially appropriate in dealing with
unknown risks.

Trusted Performance: Healthcare professionals, Oncology Units as well as EMS staff, Dental clinicians, and
Cancer Centre specialists all rely on PURPLE NITRILE* brand of exam gloves. When they see that unique
purple color, clinicians know they have protection they can trust, and that gives them the confidence to
provide the best care to every patient.

Tested Against 52 Chemotherapy Drugs as per the ASTM D6978, Standard Practice for Assessment of Resistance of Medical Gloves to
Permeation by Chemotherapy Drugs, as well as common chemicals found in the healthcare environment.

Quality Standards:
• PURPLE NITRILE* Exam Gloves have an AQL of 1.0 for critical defects.
• Meets or exceeds ASTM D6319 - Standard Specification for Nitrile Examination Glove for Medical Applications
• Meets or exceeds biocompatible 10993 studies for systemic toxicity, irritation and sensitization endpoints
• Passes Viral Penetration Testing - ASTM F1671 - 07 Standard Test Method for Resistance of Materials Used in Protective Clothing to
Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System

Clinical Considerations:
Primary material is acrylonitrile butadiene, reducing the potential for glove-associated Type I allergic reactions
Powder-free: minimizing the potential for powder related complications, such as irritant contact dermatitis
Buna Reusable Nitrile Gloves
Nitrile gloves- BUNA N15F gloves are made from our unique Nitrile formulation, this
high performance glove offers high flexibility and the anatomic formers give better
comfort while wearing the glove.
When exposed to aromatic and petroleum solvents, as well as caustics and animal Confirms to EN 374-2 for
fats, BUNA N15F gloves have proven to be a superior choice over rubber and Resistance to water & Air leak
neoprene gloves.
BUNA N15F gloves won’t swell, weaken, or degrade , and they offer strong Confirms to EN 374-3 for
protection against a wide range of chemicals, oils, solvents and very good abrasion Resistance against penetration
and puncture resistance. (A, J, K & L)
Sand pattern on the palm offers good anti slip properties.
BUNA N15F with cotton flock lining absorbs perspiration, feels comfortable on the Confirms to EN 388 for
hand, and makes donning easier puncture, abrasion, tear & cut
resistance
Material: Acrylo nitrile butadiene copolymer (NBR) latex and rubber chemicals
Colour: Green Confirms to EN 374 for
chemical resistance
Style: Raised diamond pattern
Thickness: 0.38mm (15mil) ± 0.03mm
Confirms to EN 420 for General
Lining: soft cotton flock lined requirements /design
Length: 330mm ± 10mm
Cuff: straight cut cuff. Regulatory Compliance for
Component materials comply
Design: Hand specific, curved fingers, textures finish with embossed raised diamond with FDA Regulations for food
on the finger and plan surface contact
Isolator Gloves / Sleeves
CSM (Chlorosulphonated Polyethylene)

Characteristics
Excellent chemical resistance
High resistance to Ozone and UV Colour: White
Excellent flexibility and dexterity
Excellent behaviour against ionizing radiation Port Sizes: 6”, 7”, 8”, 9”, 10”, 12”, 14”
Excellent resistance to sterilizing agents (Vaporous Hydrogen Peroxide)
Sterilization processes (Gamma and Beta radiation) Hand Styles: Ambidextrous or
Temperature Limits: -20°C – 120°C Left/Right

Fields of Application: Pharmaceutical, Nuclear Industries Hand Sizes: 8.5, 9.75, 10.5
Options: Validated Sterile (clean room laundered and gamma
irradiated) Length: 30”, 32”, 34” (+/- 1”)
Cleaning Options: Wipe with 70% Isopropyl Alcohol
Storage Conditions: Store in original packaging between 41° F to 77° F Thickness: 15 mil (0.4mm) / 24 mil
(5 ° - 25 ° C) (0.6mm)
Shelf Life 3 years from DOM
Glove Disposal: Non-recyclable Bead 0.2”(+/-0.04”)
Classified non-toxic waste if not contaminated

Packaging: Heat sealed and vacuum packaged by the pair

Hot, Cold and Wet Application Silicon Gloves
HEAT & COLD RESISTANT LIQUID SILICONE GLOVES Coating Material: Liquid Silicone
Features: Excellent Thermal Insulation Liner: Nylon 66
Special engineered formulation with patented technique. Lanon Inner Layer: CoralAirTM Adiabatic
Silicone gloves are capable of withstanding temperatures ranging from Patented Liner
minus 50° C to 250° C for an extended time and upto 298°C of not more
than few seconds. The gloves are odourless, stain-resistant, and Virus Protection: Pass EN ISO 374-
impervious to grease, easy to clean. Wash with mild dish detergent in 5:2016
hot water. Standards: EN388:2016, EN ISO 374-
1:2016/Type B, EN407:2004 (424XXX),
The patented 7 layers sandwich structure provides excellent heat & EN511:2006 (111)
cold insulation.
Main Protection
Liquid Proof: 100% liquid proof with an easy wipe off surface, ideal for High and low temperature
food and catering industry. Lab operations – WFI Application
Cold Storage – Cold Chain logistics and
Food Contact: Comply with European directive transport
Steam
Grip: Excellent grip when handling dry surface. 3D figure structure Aldehydes
designed for optimum flexibility and dexterity. Inorganic acid
Anti-microbial
Glove length: Also available in 380mm for extra protection. Inorganic base
Recommended Industries:
Food Processing
Pharma Industry
Lakeland Super- B Insert Sleeve

Advantages of Super - B Style?

 MicroMax NS
• Microporous PE film laminate
• Stitched (overlocked) seams
• Effective protection against dusts and light
liquid splash
• Fabric achieves highest class in all EN 14126
Type 5 Type 6
infectious agent tests
• Superior barrier to similar other certified
coveralls
• Soft & flexible fabric for comfort Anti-Static EN 1073
• Lakeland “Super-B” Style
MicroMax NS coverall with booty attached
Light weight disposable coverall for type 5 and 6 applications.
• Fabric: Microporous film laminate
• Weight: 65 GSM
Certifications
• Style: EMN/CTL-414/(2)
• Seam type: 3 thread over lock stitch EN 340 – Protective Clothing
• Color: white
Key features: EN 13034 – Type 6 Light Spray
• MicroMax® fabrics are the clear choice if infectious agents
• such as blood-borne pathogens may be encountered. EN 13982 – Type 5 Hazardous dry
• Superior liquid an dust protection particles
• Soft, flexible fabric for comfort EN 1073 – dust particles
• High MVTR for higher comfort level contaminated with radiation
• Lakeland “super-B” style pattern- ergonomically styled and sized for generous fit
and superior freedom of movement EN 14126 – Infectious agent
Suggested applications:
• Pharmaceutical manufacture EN 1149-5 - Antistatic Garment
• Low- level insecticide / pesticide spraying
• Wet applications in GRP manufacture
• General maintenance and cleaning applications
• Low hazard emergency response applications
Storage:
Lakeland garments can be stored in normal storage areas and require no special
condition. Keep in cool, dry areas where possible and away from direct heat and
sunlight
Disposable Gowning MicroMax® NS: Microporous film offers excellent barrier to dry particles, aerosols, and
liquids; a solid all around performer.
ChemMax Range
• Chemical Suits with barrier
increasing chemical
• Stitched & taped seams
ChemMax 1 ChemMax 2
• Double zip / storm flap front
fastening
Type 3 Type 4 Anti-Static
• Soft flexible fabrics
• Super-B Design
• Variety of styles available
EN 1073 EN 14126

ChemMax 3 ChemMax 4
ChemMax 1 coverall with booty attached

ChemMAX1is a lightweight, cost effective chemical suit for protection against splashes Certifications
and sprays of hazardous chemicals in Type 3 & 4 Applications.
EN 340 – Protective Clothing
Features:
High density polyethylene film barrier laminated to spun bond polypropylene EN 13034 – Type 6 Light Spray
substrate... For cost effective chemical protection.
Constructed with stitched and taped seams for superior protection and strength. EN 13982 – Type 5 Hazardous
Design features for double zip / storm flap front fastening for improved protection and dry particles
quick and easy donning and removal.
Lightweight and flexible material for optimum comfort and protection. EN 14605 – Type 3 & 4
Reinforced knee-pads for comfort and durability. Splashes
Bright yellow color for easy identification
EN 1073 – dust particles
Applications: contaminated with radiation
Tank and liquid chemical storage vessel cleaning.
Pressures spray applications. EN 14126 – Infectious agent
Agricultural spraying and agricultural chemical handling.
Liquid chemical handling. EN 1149-5 - Antistatic
Waste disposal. Garment
Chemical spill handling

Chemical Gowning
ChemMax 2 coverall with booty attached

ChemMax® 2 is the second level of barrier protection in the new ChemMax® line of Certifications
products from Lakeland Industries.
EN 340 – Protective Clothing
ChemMax® 2 is a superior and economical chemical protective suit developed using the
EN 13034 – Type 6 Light Spray
knowledge and expertise that you have come to expect from Lakeland. The
unparalleled strength and softness of ChemMax® 2 features Dow Saranex®23P film on EN 13982 – Type 5 Hazardous dry
two layers of a unique bi-component spun bond nonwoven substrate and provides particles
protection for chemical mixing and handling, environmental clean up, hazardous
materials remediation and response, pharmaceutical manufacturing, spray painting and EN 14605 – Type 3 & 4 Splashes
general industry.
EN 1073 – dust particles
contaminated with radiation
ChemMax® 2 is useful in protecting against hazardous chemicals and contaminants
found in the work place. EN 14126 – Infectious agent

EN 1149-5 - Antistatic Garment

Chemical Gowning
ChemMax 3 coverall with booty attached

Superior multi-layer barrier films laminated to spun bond PP substrate - 170gsm. Seam Certifications
Type: Stitched and PE taped. Double zip / storm flap front fastening
EN 340 – Protective Clothing
• Extruded fabric construction. Results in smoother and more consistent fabric than
EN 13034 – Type 6 Light Spray
bonded or glued competitors.
• Superior softness and flexibility and more consistent chemical barrier (no ‘pinching’ or EN 13982 – Type 5 Hazardous dry
thinner bond points as seen in competitor fabrics). particles
• European manufactured fabric, tested against a full range of chemical warfare agents
for anti-terror and civil defence operations. EN 14605 – Type 3 & 4 Splashes
• Very low noise level. Safer and improved comfort.
EN 1073 – dust particles
• Cushioned double-layer knee pads for increased comfort and safety.
contaminated with radiation
• Improved Super-B style coverall: superior fit, wear ability and durability.
• Three-piece hood, inset sleeves and diamond crotch gusset results in best fitting EN 14126 – Infectious agent
garment on the market.
• New design three-piece hood with tapered centre piece for superior face and EN 1149-5 - Antistatic Garment
respirator mask fit.
• New higher neck and zip flaps for improved face/neck protection.
• Double zip & storm flap front fastening for safe and secure protection..

Key features : Soft & flexible multi-layer barrier offers protection against a wide range of
chemicals. Permeation tested against a wide range of chemicals - over 2000 chemicals

Suggested applications: Higher hazard chemical protection, Petrochemical & Refining

applications, Chemical handling & distribution, Contaminated land clearance
Chemical Gowning
Oil-spill clearance, Civil defence / emergency applications.
 ChemMax 4 coverall with booty attached
Certifications ChemMax® 4 features a 7 layer protective barrier that will stand up to the toughest of hazardous
chemical environments. Weight 200 gms. Heavy Duty Chemical Splash Protection that is high in
EN 340 – Protective performance and comfort Superior multi-layer barrier films laminated to spun bond PP substrate -
Clothing 190gsm
EN 13034 – Type 6
Description: High barrier against chemicals tough to deal with such as Bromine, Diethylamine and
Light Spray
chlorobenzine. Tough and durable chemical suit
EN 13982 – Type 5
Hazardous dry Key Features
particles High barrier – handles the more “difficult” chemicals
Extruded fabric construction
EN 14605 – Type 3 & Superior softness and flexibility and more consistent chemical barrier (no ‘pinching’ or thinner bond
4 Splashes points)
Very soft and flexible materials for enhanced comfort
EN 1073 – dust Cushioned double-layer knee pads for increased comfort and safety.
particles Improved Super-B style coverall: superior fit, wear ability and durability
contaminated with Three-piece hood, inset sleeves and diamond crotch gusset results in best fitting garment on the
radiation market
New design three-piece hood with tapered centre piece for superior face and respirator mask fit.
EN 14126 – Infectious
New higher neck and zip flaps for improved face/neck protection
agent
Double zip & storm flap front fastening for safe and secure protection. Taped seams for full seal
Tough and resilient fabric – can be re-used if de-contaminated correctly
Coverall with 3 piece hood, inset sleeves, 2 piece diamond crotch gusset, elasticated hood, waist,
cuffs and ankles
Suggested Applications: Very high chemical barrier, Petrochemical and refining applications,
Chemical handling and distribution, Chemical clean-ups and spill management, Contaminated land
clearance.
Protective Eye Wear Chemical Protective Eyewear Autoclavable Cleanroom Goggles

Material: Light Weight Lens – Polycarbonate Shroud –PVC - Clear Autoclavable Cleanroom Goggles are
Polycarbonate Optical Class – Class 1 constructed in super-soft thermoplastic to
Type: Hard Coated, Weight : 70gms provide unrivalled comfort and is provided
Optical Hazard Protection : 99.9% UV Protection with indirect ventilation system.
Features: Materials : Coating : Hard Coated ( Scratch
Moulded in nose bridge provide Resistant) Characteristics: Autoclavable Goggles Indirect
same protection, Single wrap DESIGN : ventilated frame and high comfort.
around lenses provide same Sealed Fit with Head Band Can be used over Adjustable strap and clean.
protection and outstanding Prescription Glasses Unique Wrap around design Polycarbonate lens.
vision. Fully Adjustable Elastic Head Band for Snug Fit Fits over prescription glasses.
Color: Clear Single Lens Compatible with half-mask respirator.
Application : Sterilization: Autoclave at 121°C.
IS 5983 Approved Ideal for protection against and biochemical
splashes, viruses and bacteria in health care Certification: EN 166:2001 Optical Class 1.
setting. For Doctors, nurses, and all healthcare Classification: Category 2 Personal Protective
Workers. Equipment conforming to PPE Directive
89/686/EEC.
Clean room shoes
Lightweight, washable, safety shoes, comfortable, Anti Skid, easy to
wear.
Resin complies with FDA 21 CFR 177.1350 (a)(1). Made from Rikilite P1
Resins.
Chemical Resistant
Light Weight with composite toe – 200 gms / piece
Uni-Mould design to ensure there is no stitch / no paste
Sole: Wave grip sole does not accumulate dust / other particles and
anti-slip properties.
Colours: White, Blue, Black & Brown.
Uni-Sex design
Size 2 – 12
Extra Thick Sole for Anti Fatigue & whole day comfort
Application: Clean room, Food Industry & Laboratories.
 MICROPURE LP WIPE
The Cleanest One Around: This remarkable Sontara® low particle fabric was specifically developed to obtain a high
level of cleanliness and purity without sacrificing absorbency. Made using jet filtered, high-pressured water,
Sontara® fabric is continually “washed” during manufacture. This patented process requires no binders or additives.
The Sontara® MicroPure LP Wipe is the cleanest high-absorbency nonwoven fabric available. Unlike knits, which
often require additional handling for laundering and sealing edges, Sontara® fabric does not require intermediate
processing. Special blend of polyester and lyocell

Benefits
■ Exceptionally clean wiper fabric with extremely low particle generation, low extractable and ion levels
■ More absorbent than 100% polyester
■ Excellent wet and dry strength; solvent resistance
■ Extremely soft wiper fabric
■ Double bagged
■ ISO 9001-2008 certification
■ Autoclaveable
Recommended for
■ Class 10 (M2.5) and higher cleanrooms
■ Wiping delicate surfaces
■ Packaging sensitive components
■ Cleaning work surfaces
■ General cleanroom maintenance
Waterproof Cryo –Suit / Gloves / Apron protect your hands and arms when working in
hazardous, ultra-cold environments. They are designed to provide a high level of
thermal protection where the exposure to cryogenic fluids. Made from state-of-the-
art materials, waterproof cryogenic products are designed to work in comfort for
extended periods of time.

A thin, seamless 100% waterproof liner provides protection from spills and splashes.
Multi-layered construction allows for a maximum level of thermal protection,
flexibility, and dexterity—essential features when function is important and safety is
critical.

FEATURES
Maximum Thermal Protection
Water Proof
Lightweight and Comfortable
Excellent Dexterity
Breathable and Stay-dry Lining

Application: Bio-Medical Labs, Clinical Labs, Blood Labs, Fertility Clinics,

Pharmaceuticals, Genetics and Biotechnology, Cryo-Preservation Facilities,
Liquid Spill Response, Environments where cryogenic Liquids are handled.
 Spill Kit
Key features
High visibility yellow
Fire retardant as per ASTM 726.
Ensure that disposal of these sorbents complies with all relevant national regulations and
guidelines.

Pads: Single layer of meltblown polypropylene (40 cm x 50 cm)

Absorbency: 0.65 Litres of oil / 0.36 Litres of water per pad. Offers an absorbent with the
lowest cost per square metre.
Weight 190 gsm

Socks: Spun Bond outer sleeve filled with absorbent core. Pillow: Spun Bond polypropylene outer sleeve filled
(8 cm x 120 cm) with absorbent core. (40 cm x 50 cm)
Absorbency: 6.05 Litres of oil / 6.45 Litres of water per sock. Absorbency: 2.5 Litres of oil / 6.80 Litres of water per
Will not become slippery even when fully saturated. pillow.
Contains no poly-acrylate. Will not become slippery even when fully saturated.
No lint spun-bond outer sleeve. Contains no poly-acrylate.
Contains 95% recycled content. No lint spun-bond outer sleeve.
Contains proprietary Super Absorbent Flake. Contains 95% recycled content.
Contains proprietary Super Absorbent Flake Core.
 Cytotoxic Spill KitSpill Kit
Lightweight and portable for intensive and frequent use on Multiple and/or large scale
spillages. High Absorbency Cyto Granules absorb and contain liquid spills. Absorbent pads
and sterile water mop up powder spills. Our custom Cytali solution, designed to neutralize
cytotoxic residue of spill Site and surrounding area. Warning signs and colour coded,
sealable bags for safe disposal.

Safe for Use by non-specialist staff in hospitals, clinics, surgeries, outpatient departments,
pharmacies, laboratories; nursing and care homes and other locations where cytotoxic or
chemotherapy drugs are handled and stored

KIT CONTENTS
Protective Equipment • 3 pairs of disposable gloves* • 3 thumb loop gown • 3 FFP3 mask
• 3 eye
visor • 3 pairs of over sleeves • 3 pairs overshoes • 1 kneeling pad
Liquid Clean up • 3 Cyto Granule 50g sachet • 3 scoop scraper • 1 tweezers
Powder Clean up • 3 sterile water pods • 3 absorbent pads Decontamination • 3 Cytali
Powder 10g sachet • 1 250ml diluter • Paper towels
Waste disposal • 1 instruction sheet • 3 Cytotoxic waste bag • 3 bag tie • 1 warning sign •
1 record card
Bouffant Cap Disposable Shoe Cover Polyester Wipes

Gas detection – Portable and Fixed Reusable Lint Free Gowning Aceptic Gowning
Thanking you

Virag J Shah| Area Sales Manager|

M: +91 9978621033 | Email : virag@abcbrothers.in|

Corporate Office:
|“ABC House” |14-15 Shivam Estate |Near Ujala Circle |
|Sarkhej |S. G. Highway |Ahmedabad – 382 210 |
Gujarat |INDIA |
|T: +91 79 26890331 / 4 / 9 | Extn: 614

ISO 9001: 2015 Quality Management System