2. CONTENTS:
INTRODUCTION
CONTAINERS
TYPES OF CONTAINERS
ADVANTAGES
MATERIALS USED FOR MANUFACTURE OF
CONTAINERS AND THEIR COMPOSITION
CONTAINERS USED FOR OPTHALMIC AND
PARENTRALS PREPARATIONS
MATERIALS USED FOR CONTAINERS AND THEIR
COMPOSITION
EVALUATION OF THE MATERIAL USED FOR MAKING
OF CONTAINERS.
3. INTRODUCTION
CONTAINERS CAN BE DEFINED AS AN OBJECT THAT
CAN BE USED TO HOLD OR TRANSPORT
SOMETHING.
PHARMACEUTICAL CONTAINER IS A DEVICE THAT
HOLD THE PHARMACEUTICAL PRODUCT AND IT MAY
OR MAY NOT BE IN DIRECT CONTACT WITH IT.
4. WHY WE DO PACKING OF
DRUGS IN CONTAINERS?
PACKAGING CAN BE USED AS THE ECONOMICAL
MEANS OF PROVIDING PRESENTATION,
PROTECTION, IDENTIFICATION, INFORMATION,
CONVENIENCE, COMPLIANCE (CONFORMITY),
INTEGRITY AND STABILITY OF THE PRODUCT.
5. CLASSIFICATION OF THE
PACKAGING
PACKAGING
PRIMARY PACKAGING MATERIAL SECONDARY PACKAGING
TERTIARY
FOR TABLETS OR CAPSULE LIKE UNITS MATERIAL
PACKAGING
DOSAGE FORMS PAPERS AND BOARDS
MATERIAL
BLISTER PACK ,STRIPE PACK,GLASS BOTTLE, CARTONS
CORRUGATED BOX
PLASTIC BOTTLES BROWN CARD
BOARD BOX
FOR LIQUID PREPARATION WOOD PALLETS
VAILS,AMPOULES,CATRIDGES,GLASS BOTTLES, SHRINK
WRAP
PLASTIC BOTTLES
FOR POWDERS AND GRANULES
FOIL,PAPER OR PLASTIC POUCH,GLASS OR PLASTIC
BOTTLES.
FOR SEMI SOLID PREPARATIONS
COLLAPSIBLE TUBE
FOR SUPPOSITORIES
FILM WRAPPERS
CONTAINERS FOR AEROSOLS
6. THE MATERIALS SELECTED MUST
HAVE FOLLOWING
CHARACTERISTICS
THEY MUST PROTECT THE PREPARATION FROM
ENVIRONMENT CONDITIONS.
THEY MUST NOT BE REACTIVE WITH THE PRODUCT.
THEY MUST NOT IMPART TO THE PRODUCT TESTES OR
ODORS AND COLOR CHANGE.
MUST BE NON TOXIC.
THEY MUST BE “FDA” APPROVED.
THEY MUST MEET APPLICABLE TAMPER- RESISTANCE
REQUIREMENTS.
THEY MEST BE ADAPTABLE TO COMMONLY EMPLOYED
HIGH-SPEED PACKAGING EQUIPMENT.
7. COMPONENTS OF
PACKAGING
CONTAINERS- REFERS TO STORAGE MEDIA IN WHICH
PRODUCT IS PLACED AND ENCLOSED AND IT IS IN
DIRECT CONTACT WITH THE DRUG (GLASS, PLASTIC).
CLOSURES- IS A DEVICE TIGHTIY PACK THE CONTAINER TO
EXCLUDE O2 , CO2 , MOISTER AND MICRO O/S AND
PREVENT LOSS OF WATER & VOLATILE SUBSTANCE
FROM THE PRODUCT DURING TRANSPORT & HANDLING .
IT IS A PART OF CONTAINER SYSTEM BUT DOESN’T
COME IN CONTACT WITH DRUG (ALUMINUM, RUBBER).
8. CARTONS : OUTER COVERING WHICH GIVES PROTECTION
AGAINST MECHANICAL AND ENVIRONMENTAL HAZARDS
ALSO DISPLAY WRITTEN INFORMATION (CARDBOARD).
BOX A DEVICE WHICH IS GENERALLY USED FOR
PACKAGING OF PRODUTS. IT GIVES PRIME PROTECTION
AGAINST EXTERNAL HAZARDS PROVIDED CONTAINMENT &
ABSORBS SHOCKS (CARDBOARD & WOOD).
10. QUALITIES OF GOOD CONTAINER
THE CONTAINER MUST BE NEUTRAL TOWARDS THE
MATERIAL WHICH IS STORED IN IT.
THE CONTAINER MUST NOT INTERACT PHYSICALLY OR
CHEMICALLY WITH THE SUBSTANCE WHICH IT HOLDS.
IT SHOULD HELP IN MAINTAINING THE STABILITY OF
PRODUCT AGAINST THE ENVIRONMENTAL FACTORS
WHICH CAUSES ITS DETERIORATION.
11. IT SHOULD BE MADE OF MATERIALS
WHICH CAN WITHSTAND WEAR AND TEAR
DURING NORMAL HANDLING.
IT SHOULD BE ABLE TO WITHSTAND
CHANGE IN PRESSURE AND TEMPERATURE.
THE MATERIALS USED FOR MAKING OF
THE CONTAINER MUST BE NON-TOXIC.
SURFACE OF THE CONTAINER MUST BE
CLEAR FOR EASY LABELLING.
SIZE OF THE CONTAINER MUST BE
SELECTED ACC. TO THE SIZE OF
PREPARATION.
THEY SHOULD NOT ALLOW ANY LOSS
PRODUCT DURING LEAKAGE , SPOILAGE
OR PERMEATION.
12. TYPES OF CONTAINERS
CONTAINERS ARE DIVIDED INTO FOLLWING TYPES ON
THE BASIS OF THEIR OF THEIR UTILITY.
WELL-CIOSED CONTAINERS: A WELL - CLOSED CONTAINER
PROTECTS THE CONTENTS FROM LOSS DURING
TRANSPORTATION , HANDLING , STORAGE OR SALE.
Example: AMPOULES AND VIALS
SINGLE DOSE CONTAINERS : THERE CONTAINERS ARE
USED TO SUPPLY ONLY ONE OF MEDICAMENT AND HOLD
GENERALLY PARENTERAL PRODUCTS.
13. MULTI DOSE CONTAINERS : THERE CONTAINERS ALLOW
THE WITHDRAWAL OF DOSE AT VARIOUS INTERVALS
WITHOUT CHANGING THE STRENGTH , QUALITY OR
PURITY OF REMAINING PORTION THESE CONTAINERS
HOLD MORE THAN ONE DOSE ARE USED FOR
INJECTABLE. Example:.VIALS
LIGHT-RESISTANT CONTAINERS : THESE CONTAINERS
PROTECT THE MEDICAMENTS WHICH ARE PHOTO-
SENSITIVE.
14. AIR TIGHT CONTAINERS : THESE ARE ALSO CALLED
HERMETIC CONTAINERS. THESE CONTAINERS HAVE AIR-
TIGHT SEALING OR CLOSING. THESE CONTAINERS
PROTECT THE PRODUCTS FROM DUST MOISTURE AND
AIR WHERE AS AIR-TIGHT SCALED CONTAINERS ARE
USED FOR INJECTABLE AIR-TIGHT CLOSED CONTAINER
ARE MEANT FOR THE STORAGE OF OTHER PRODUCTS.
AEROSOL CONTAINER: THESE CONTAINERS ARE UESD
TO HOLD ASROSOL PRODUUCTS. THESE CONTAINERS
HAVE ADEQUATE MECHANICAL STRENTH IN ORDER TO
BEAR THE PRESSURE OF AEROSOL PACKING.
15. CHILD-PROOF CONTAINERS: A CONTAINER THAT IS FITTED
WITH A CLOSER THAT PREVENTS OPENING BY CHILDREN.
CHILD-RESISTANCE PACKAGE TESTING :
CRITIQUE OF DIRECTION FOR PACKAGE/PRODUCT-USE
PACKAGE PREFERENCE
PRODUCT PREFERENCE
SWALLOW ABILITY TESTING
16. MATERIAL USED FOR
MANUFACTURE OF CONTAINERS
THERE ARE MAINLY FOUR TYPES OF
MATERIAL USED IN MANUFACTURE OF
CONTAINERS:
GLASS
PLASTIC
METAL
RUBBER
17.
18. GLASS CONTAINERS
GLASS HAS BEEN WIDELY USED PACKAGING MATERIAL.
FOR A LARGE NUMBER OF INCLUDING MEDICINAL
PRODUCTS FOR ORAL AND LOCAL ADMINISTRATION
GLASS CONTAINERS ARE USUALLY THE FIRST CHOICE
(Example: BOTTLES FOR TABLETS, LOTIONS OR INHALERS).
19. COLOURED GLASS
CONTAINERS
IS OBTAINED BY THE ADDITION OF SMALL AMOUNTS OF
METAL OXIDES , CHOSEN ACCORDING TO THE DESIRED
SPECTRAL ABSORBANCE.
PRICIPALLY GLASS IS SILICON DIOXIDE TETRAHEDRON
WHOSE PHYSIOCHEMICAL PROPERTIES ARE ALTERED BY
ADDING OXIDES OF SODIUM IRON MAGNESIUM ETC.
20. TYPES OF GLASS
TYPE 1-BOROSILICATE GLASS (NEUTRAL GLASS):
IT IS HIGHLY INSERT TYPE OF PHARMACEUTICAL GLASS.
IT HAS HIGH MELTING POINT SO CAN WITH STAND HIGH
TEMPERATURES RANGE.
IT CAN RESIST STRONG ACID ALKALIES AND ALL TYPES
OF SOLVENTS.
REDUCED LEACHING ACTION.
USES:
LABORATORY GLASS APPARATUS .
FOR INJECTION AND WATER FOR INJECTION.
WIDELY USED AS GLASS AMPOULE AND VIALS.
21. NOTE:-
EXCEPT FOR TYPE 1 GLASS CONTAINERS, GLASS
CONTAINERS FOR PHARMACEUTICAL PERPARATIONS ARE
NOT TO BE RE-USED.CONTAINERS FOR HUMAN BLOOD
AND BLOOD COMPONENTS MUST NOT BE RE-USED.
22. TYPE 11-TREATED SODA LIME GLASS:
TYPE 11CONTAINERS ARE MADE OF COMMERCIAL SODA
LIME GLASS THAT HAS BEEN DEALKALISED OR TREATED
TO REMOVE SURFACE ALKALI.
THE DE-ALKALISED PROCESS IS KNOW AS SULPHUR
TREATMENT.
SULPHUR TREATMENT NEUTRALIZES THE ALKALINE
OXIDES ON THE SURFACE RENDERING THE GLASS MORE
CHEMICALLY RESISTANT.
USES:
USED FOR ALKALI SENSITIVE PRODUCTS.
INFUSION FLUIDS, BLOOD AND PLASMA.
LARGE VOLUME CONTAINER.
USED TO PRODUCE CONTAINER FOR EYE PREPARATIONS.
23. TYPE-111 REGULAR SODA LIME GLASS:
CONTAINERS ARE UNTREATED ARE MADE OF
COMMERCIAL SODA LIME GLASS.
IT CONTAINS HIGH CONCENTRATION OF ALKALINE OXIDES
AND IMPARTS ALKALINITY TO AQUEOUS SUBSTANCES.
FLAKES SEPARATE EASILY.
USES:
FOR ALL SOLID DOSAGE FORMS.
FOR OILY INJECTIONS.
FOR NON AQUEOUS PARENTERAL PRODUCTS.
24. TYPE 4 NP- GENERAL PURPOSE SODA LIME GLASS:
CONTAINERS ARE MADE OF SODE LIME GLASS SUPPLIED
FOR NON PARENTERAL PRODUCTS INTENDED FOR ORAL
OR TOPICAL USE.
USES:
FOR ORAL USE.
FOR SOILD LIQUID PREPARATIONS.
25. OVERVIEW OF GLASSES USED IN PHARMACEUTICAL
PRACTICE
GLASS TYPE GENERAL
DESCRIPTION
TEST METHOD USES
TYPE 1
HIGHLY
RESISTANT
BOROSILICATE
GLASS
POWDERED
GLASS TEST
FOR BUFFERED AND
UNBUFFERED
AQUEOUS SOLUTIONS
POWDERS
TYPE 2 TREATED
(SULPHUR
DIOXIDE FUMES)
SODA LIME
GLASS
WATER ATTACK
TEST
FOR BUFFER
AQUEOUS SOLUTION
WITH PH BELOW 7
AND FOR DYE
POWEDERS
TYPE 3 SODA LIME
GLASS
POWDERED
GLASS TEST
FOR DRY POWDERS
AND OLEGINOUS
SOLUTION,NOT FOR
AQUEOUS
PREPARATIONS
TYPE 4 GGENERAL SODA
LIME GLASS
POWERED GLASS
TEST
NOT FOR
PARENTERALES AND
FOR SUSPENSION AND
26. TYPES OF GLASS
CONTAINERS
BOTTLES:
USED IN THE DISPENSARY FOR PACKAGING OF MEDICINE
WHICH ARE AVAILABLE IN SIZES FROM 50ML TO 500ML.
TYPES:
AMBER METRIC MEDICAL BOTTLES:- WIDEIY USED FOR
PACKAGING OF ORAL MEDICINES.
27. RIBBED (FLUTED) OVAL BOTTLES:- ARE USED TO PACKAGE
VARIOUS PRODUCT THAT SHOULD NOT BE TAKEN
ORALLY.
WIDELY USED FOR PACKING OF LINIMENTS LOTION
INHALATION AND ANTISEPTIC SOLUTION.
28. LARGE VOLUME PARENTERAL
GLASS BOTTLES
THE PARENTERAL PRODUCTS ARE PACKED AND
ADMINISTERED IN LARGE VOLUME I,E . 100ML TO 1000ML
PER DAY.
FOR LVP, TYPE 2 GLASS IS USED BUT TYPE 1 CAN ALSO
BE USED FOR THE PRODUCTS HAVING HIGH pH.
29. DROPPER BOTTLES
EYE DROP AND DROPPER BOTTLES FOR EAR AND NASAL
USE ARE HEXAGONAL – SHAPED AMBER COLOR GLASS
CONTAINERS.
THEY ARE FITTED WITH CAP, RUBBER TEAT AND DROPPER
AS THE CLOSURE.
THE BOTTELS ARE USED AT A CAPACITY OF 10ml to 20ml.
30. JARS
POWDERS AND SEMISOLID PREPARATIONS ARE
GENERALLY PACKED IN WIDE MOUTHED CYLINDRICAL
JARS MADE OF CLEAR OR AMBER GLASS.
JARS VARIES FROM 15ml to 500ml.
JARS ARE USED FOR PACKING PERPARED OINTMENTS
AND PESTES.
31. AMPOULE
AN AMPOULE (ALSO AMPOULE , OR AMPULLA ) IS A SAMLL
SEAKED VIAL WHICH IS USED TO CONTAIN AND
PRESERVE A SAMPLE USUALLY A SOLIDE OR LIQUID.
AMPOULES ARE COMMLY MADE OF GLASS. ALTHOUGH
PLASTIC AMPOULES DO EXIST.
THESE ARE USED FOR PACKING OF PARENTERAL
SOLUTION INTENDED FOR SINGAL USE. GLASS
AMPOULES ARE MORE EXPENSIVE THAN BOTTLES AND
OTHER SIMPLE CONTAINERS .
32. TYPES OF
AMPOULES
ONE POINT CUT AMPOULES :
BEFORE OPENING ONE POINT CUT (OPC) AMPOULE.
USE AN ANTISEPTIC TO CLEAN THE AMPOULE.
GENTLY TAP THE TOP PART OF THE AMPOULE TO GET
ALL THE LIQUID INTO THE BOTTEM PART.
33. DIRECTIONS FOR USE OF ONE-
POINT CUT (OPC) AMPOULE
HOLD THE BOTTEM PART OF THE AMPOULE WITH THE COLOURED
DOT FACING YOU .
PUT THE OTHER HAND ON THE TOP OF THE AMPOULE AS SHOWN.
34. APPLY PRESSURE TO THE TOP PART AND SNAP THE AMPOULE
AWAY FROM YOU.
FEATURES: LONG TEASTING STRUCTURE PERFECT FINISHING
RESISTANCE TO CHEMICALS.
35. FLAT BASED AND CONSTRICTED
NECK AMPOULE
FEATURES:
OPTIMUM HYGIENE LEVEL.
LONGER SERVICE LIFE.
36. FLAME CUT
AMPOULES
OPTIMUM HYGIENE LEVEL.
EASE IN STERILIZATION.
CAN BE EASILY BROKEN TO TAKE OUT THE PRODUCT.
37. VIALS
A GLASS OR PLASTIC CONTAINER CLOSED WITH A
RUBBER STOPPER AND SEALED WITH AN ALUMINUM
CRIMP. VIRLS ARE AVAILABLE FOR SINGLE. DOSING OR
FOR MULTIPLE DOSING.
INJECTION VIRALS CAN BE OBTAINED IN EITHER
NEUTRAL OR SODA GLASS AND OCCASIONALLY IN
TREATED SODA GLASS.
38. ADVANTAGES AND DISADVANTAGES
OF GLASS VIAL
ADVANTAGES:
GLASS VIRAL HAS INCREASED DOSE FLEXIBILITY.
HAS DECREASE COST PER UNIT DOSE.
COST OF HANDLING TRANSPORTATION AND STORAGE IS
LESS.
DISADVANTAGES:
CLOSURES FRAGMENT MAY BE RELEASED INTO THE
PRODUCT WHEN NEEDLE IS INSERTED THROUGH THE
CLOSURE.
RISK OF INTERACTION BETWEEN PRODUCT AND
CLOSURE.
REPEATED WITHDRAWN OF INJECTION SOLUTION
INCREASE THE RISK OF MICROBIAL CONTAMINATION.
39. ADVANTAGES OF GLASS
CONTAINERS
IT ALLOWS EASY INSPECTION OF THE CONTAINER CONTENTS.
IT ALSO HAVE THE GREAT ADVANTAGE OF PRESERVING A
CERTAIN TEMPERATURE FOR A LONGER PERIOD OF TIME. THEY
DO NOT DILATE WHEN IT IS TOO WARM OR SHRINK. WHEN
EXPOSED TO LOWER TEMPERATURE.
THEY ARE AVAILABLE IN VARIOUS SHAPES AND SIZES.
THEY ARE ECONOMICAL AND READILY AVAILABLE.
THEY CAN PROCTECT THE PHOTOSENSITIVE MEDICAMENTS
FROM LIGHT DURING THEIR STORAGE.
THEY DO NOT DETERIORATE WITH AGE.
40. DISADVANTAGES OF GLASS
CONTAINERS
THEY ARE BRITTLE AND BREAK EASILY.
THEY MAY CRACK WHEN SUBJECT TO SUDDEN CHANGE
IN TEMPERATURES.
THEY ARE HEAVIER IN COMPARISON TO PLASTIC
CONTAIMERS.
THEY CAN CAUSE LIGHT TRANSMISSION.
41.
42. PLASTIC CONTAINERS
PLASTIC ARE SYNTHETIC POLYMERS OF HIGH
MOLECULER WEIGHT.
PLASTICS AS PACKAGING HAVE PROVEL USEFULL FOR A
NUMBER OF REASON:
1. EASE WITH WHICH IT CAN BE FORMED.
2. DURABILITY AND FLEXIBILITY.
3. THE FREEDOM TO DESIGN.
4.PLASTIC CONTAINERS ARE EXTREMELY RESISTANT
TO BREAKAGE AND OFFER SAFETY CONSUMERS.
43. DRUG-PLASTIC
CONSIDERATIONS
A PACKAGING SYSTEM MUST PROTECT THE DRUG
WITHOUT ALTERING THE COMPOSITION OF THE PRODUCT
UNTIL THE LAST DOSE IS REMOVED.
DRUG-PLASTIC CONSIDERATIONS HAVE BEEN DIVIDED
INTO FIVE CATEGORIES:
1. PERMEATION
2. LEACHING
3. SORPTION
4. CHEMICAL REACTION
5. ALTERATION
44. PERMEATION:
IT IS THE TRANSMISSION OF GASES
VAPORS OR LIQUIDS THROUGH PLASTIC
PACKAGING MATERIAL.
PERMEATION OF WATER VAPOUR AND
OXYGEN THROUGH PLASTIC WALL INTO
THE DRUG IS A MAJOR PROBLEM IS THE
DOSAGE FORM IS SENITIVE TO
HYDROLYSIS AND OXIDATION.
THE VOLATILE INGREDIENTS MIGHT
CHANGE WHEN STORED IN PLASTIC
CONTAINERS AND THE TASTE OF THE
MEDICINAL PRODUCTS MAY CHANGE FOR
THE SAME REASON OF PERMEATION.
45. LEACHING:
SOME PLASTIC CONTAINERS HAVE
ONE OR MORE INGREDIENTS ADDED
TO STABILIZE IT THESE MAY LEACH
INTO THE DRUG PRODUCT.
PROBLEM MAY ARISE WITH PLASTIC
WHEN COLORING AGENTS ARE
ADDED IN SMALL QUANTITIES TO
THE FORMULA.
PARTICULAR DYE MAY MIGRATE INTO
THE PARENTAL SOLUTION AND
CAUSE A TOXIC EFFECT.
46. SORPTION:
THIS PROCESS INVOLVES THE
REMOVABLE OF CONSTITUENTS
FROM THE DRUG PRODUCT BY YHE
PACKING MATERIAL.
THE THERAPEUTIC EFFICACY OF
THE PRODUCT MAY BE REDUCED
DUE TO SORPTION.
SORPTION MAY CHANGE THE
CHEMICAL STURCTURE, PH.,
SOLVENT SYSTEM , CONCENTRATION
OF ACTIVE INGREDIENTS AND
TEMPERATURE ETC..
47. CHEMICAL REACTIVITY
CERTAIN INGREDIENTS IN PLASTIC FORMULATIONS
MAY REACT CHEMICALLY WITH ONE OR MORE
COMPONENTS OF THE DRUG PRODUCT.
EVEN IN MICRO QUANTITIES IF INCOMPATIBILITY
OCCURS MAY ALTER THE APPEARANCE OF THE
PLASTIC OR THE DRUG PRODUCT.
MODIFICATION:
THE PHYSICAL AND CHEMICAL ALTERATION OF THE
PACKING MATERIAL BY THE DRUG PRODUCT IS
CALLED MODIFICATION.
SOME SOLVENT SYSTEM FOUND TO BE
COSIDERABLE CHANGE IN THE MECHANICAL
PROPERTIES OF THE PLASTICS.
FOR EXAMPLE OILS HAVE A SOFTENING EFFECT
ON POLYENTHYLENE, HYDROCARBON ATTACK
POLYETHYLENE AND PVC.
48. TYPES OF PLASTICS
THERE ARE TWO MAIN TYPES OF PLASTICS:-
THERMOPLASTICS
THESE ARE SOFTENED BY HEAT AND CAN BE MOULDED.
THERMOPLASTIC POLYMERS HAVE BEEN ESTABLISHED AS
PACKING MATERIAL FOR STERILE PREPARATIONS SUCH
AS LARGE VOLUME PARENTERAL, OPHTHALMIC SOLUTION
AND ALSO SMALL VOLUME PARENTERAL.
GOOD EXAMPLE ARE ACRYLIC, POLYPROPYLENE,
POLYSTYRENE POLYTHENE AND PVC.
49. THERMO SETS PLASTICS:
THESE ARE FORMED BY HEAT PROCESS BUT ARE THEN
SET (LIKE CONCRETE)AND CANNOT CHANGE THE SHAPE
BY REHEATING.
HARDEN REVERSIBLY BY CROSS LINKING.
GOOD EXAMPLE ARE MELAMINE (KITCHEN ,WORKTOPS
),BAKELITE (BLACK SAUCEPAN HANDLES), POLYESTER
AND EPOXY RESINS.
50. OTHER
CLASSIFICATIONSPLASTIC ARE OF TWO FORMS
AMORPHOUS PLASTIC CRYSTALLINE PLASTIC
THEY GIVE GOOD
TRANSPARENCY.
THEY ARE HARD BUT
POSSES LITTLE BRITTLENESS.
THEY ARE MORE PERMEABLE
TO GASSES AND VAPOUR.
THEY ARE OF LESS INERT.
THEY ARE OPAQUE.
THEY AREMORE FLEXIBLE.
THEY ARE LESS PERMEABLE
TO GASSES AND VAPOUR .
FOR PHOTO SENSITIVE DRUGS
THIS TYPE OF PLASTICS ARE
SELECTED.
MORE INERT
51. POLYETHYLENE
IT FLEXIBLE ,VERY LIGHT BUT TOUGH PLASTIC.
IT IS IMPERMEABLE TO WATER VAPOUR AND DOES NOT
DETERIORATE WITH AGE UNLESSIT EXPOSED TO SUN LIGHT
FOR A LONG TIME .
IT HAS PERMEABILITY TO CERTAIN OILS AND
PRESERVATIVES.
ITS MELTING POINT BEING IN THE RANGE OF 110 to 150.
IT HAS HIGH MELTING POINT AND CAN STERILIZED BY
AUTOCLAVING.
52. IT IS DIVIDED INTO:
HDPE [HIGH DENSITY POLY ETHELENE ]
LDPE [LOW DENSITY POLY ETHELENE ]
HDPE : RIGID,WITHSTAND TEMPERATURE UP TO 120
DEGREE CELSIUS.
LDPE :FEXIBLE ,WITHSTAND TEMPERATURE UPTO 80
DEGREE CELSIUS.
53. USES OF POLY ETHELENE
AND POLY PROPYLENE
THESE ARE WIDELY USED IN PARENTERAL PLASTIC
CONTAINERS.
LOW DENSITY POLY ETHYLENE AND POLY PROPYLENE
ARE GENERALLY NOT AUTO CLAVABLE.
POLY ETHELENE CONTAINERS ARE MOSTLY USED FOR
OPHTHALMIC PREPARATIONS.
54. POLY VINYL CHLORIDE
[PVC]
IT IS LESS FLEXIBLE ,HEAVIER AND MORE PERMEABLE TO
WATER VAPOUR AS COMPARED WITH NORMAL
POLYTHENE.
IT HAS HIGH CLARITY AND NOT EFFECTED BY SUNLIGHT.
IT IS USED FOR PREPARING EYE OINTMENT TUBES.
FLEXIBLE PVC IS MAIN COMPOUND FOR INTRAVENOUS
BAGS.
55. POLY STERENE
IT IS A HARD, RIGID ,LIGHT MATERIAL.
IT CAN BE EASILY MOULDED INTO ANY SHAPE.
SO IT IS USED FOR PREPARING BOTTLES ,TUBES ,JARS
FOR OINTMENT AND CREAM, BOXES AND SYRINGES.
56. POLY METHYL METHACRYLATE
[PMMA]
IT IS HARD, STRONG BUT LIGHT ,TRANSPARENT PLASTIC.
IT SOFTENTS AT ABOUT 100 DEGREE CELSIUS.
IT IS USED FOR PREPARING BOTTLES AND TUBES.
57. POLY CARBONATE
IT IS TRANSPARENT, HAS HIGH IMPACT STRENGHT AND
VERY GOOD HEAT RESISTANCE.
IT IS USED IN THE PREPARATION OF SURGICAL
EQUIPMENT.
IT HAS USED IN BLOOD OXYGENATORS , BLOOD
RESERVOIRS AND BLOOD FILTERS USED IN THE BYE
PASS CIRCUIT FOR MORE THAN 20 YEARS.
58. TYPES OF PLASTIC
CONTAINERS
PLASTIC AMPOULES
ADVANTAGES
1) BREAKING IS EASY , NO SHREDS ,NO SHARP EDGES, NO
DANGER FOR SCARS OR CUTS OF THE SKIN.
2) PLASTIC AMPOULES IS NOT FRAGILE, NO NEED FOR
SPECIAL HANLDLING WITH CARE DURING SHIPMENT
,STORAGE OR THE FINAL APPLICATION .
3) FILLING UP DOES NOT NEED THE EXPENSIVE AND
HAZADOUS TECHNOLOGY OF FLAME WELDING.
59. 4) IT IS EASY AND ENERGY EFFICIENT ON AUTOMATIC PROCESS
MACHINES ,WITH HIGH PRECISION OF DOSING .
5) THE RAW MATERIAL IS ENVIRONMENTAL FRIENDLY AND FULLY
RECYCLABLE POLY PROPYLENE .SIZE RANGE IS :-1.5ml ,3ml, 5ml, 7ml
,11ml.
DISADVANTAGES OF PLASTIC AMPOULES:-
1) NOT AS TRANSPARENT AS GLASS.
2) LEACHING MAY OCCUR.
3) DIFFICULT IN STERILIZATION.
4) CAN’T TOLERATE HIGH TEMPERATURE RANGE.
60. PLASTIC VIALS
PLASTIC VIALS ,OFTEN USED TO STORE MEDICATION AS LIQUID
POWERS OR CAPULES.
THEY CAN ALSO USED AS SAMPLES VESSELS , FOR INSTANCE
IN AUTO SAMPLER DEVICIN ANALYTICAL CHROMATOGRAPHY.
MODERN VIALS ARE OFTEN MADE OF PLASTICS SUCH AS
POLYPROPYLENE.
61. PLASTIC TUBES
o DURING THE LAST DECADE , PLASTIC BLOOD COLLECTION
TUBES HAVE BEEN PROGREEIVELY REPLACING PLASTIC
TUBES.
o PLASTIC TUBES ARE NOT ONLY LESS EXPENSIVE BUT
ALSO SAFER THAN GLASS TUBES ,BECAUSE THEY ARE
LESS LIKELY TO BREAK.
o THEY HAVE BEEN SHOWN TO INFLUENCE THE
MEASURED CONCENTRATION OR STABILITIES OF
SEVERAL DRUGS.
62. PLASTIC SYRINGE
A SYRINGE IS A SIMPLE PUMP CONSISTING OF A PLUNGER
THAT FITS TIGHTLY IN A TUBE.THE PLUNGER CAN BE PULLED AND
PUSHED ALONG INSIDE A CYLINDRICAL TUBE CALLED A BURREL,
ALLOWING THE SYRINGE TO TAKE IN AND EXPEL THE LIQUID OR
GAS THROUGH AN ORIFICE AT THE OPEN END OF THE TUBE.THE
OPEN OF THE SYRINGE MAY BE FITTED WITH A HYPODERMIC
NEEDLE ,TO HELP DIRECT THE FLOW INTO AND OUT OF THE
BARREL.SYRINGES ARE OFTEN USED TO ADMINISTER INJECTIONS,
INSERT INTRAVENOUS DRUGS INTO THE BLOODSTREAM.
63. PVC COLLAPSABLE BAGS
IT IS THE PART OF LARGE VOLUME PARENTERAL
PRODUCTS [00ml -1000ml /DAY] CONTAINERS.
THEY ARE USED TO PACK MOST INFUSION FLUIDS.
THEY ARE DESIGN WITH A PART FOR THE ATTACHMENT
OF ADMINISTER ATION SET AND ADDITIVES PART FOR
THE ADDTION OF SMALL PARENTERAL FLUID.
64. ADVANTAGES:-
1) DURABLE AND LIGHT WEIGHT.
2) NOT AIR INTERCHANGE. THE BAG COLLAPSES AS IT
EMPTIES.
DISADVANTAGES:-
1) THEY ABSORB SOME DRUGS.
2) THEY PERMIT A HIGH MOISTURE PENETRATION.
ETHYLENE VINYL ACETATE FILM {EVA} ARE
ALSO USED IN THE FORMATION OF FLEXIBLE
COLLAPSABLE TUBE.
65. SEMI RIGID POLYTHENE
CONTAINERS
THESE CONTAINERS ARE USED FOR DIFFERENT VOLUME
OF PARENTRAL PRODUCTS :
1. 100ml FOR ELECTROLYTE SOLUTION.
2. 3 LITRE FOR TOTAL PARENTRAL NUTRITION SOLUTION.
3. UPTO 5ml FOR DIALYSIS SOLUTION.
66. STERILIZATION OF PLASTIC
CONTAINERS
METHODS OF STERILIZATION STERILIZATION CONDITION
MOIST HEAT 121 DEGREE CELCIUS FOR 15
MINUTES
DRY HEAT 160 DEGREE CELCIUS FOR 1 – 3
HOURS
GASEOUS STERILIZATION ETHYLENE OXIDE WITH NEGATIVE
PRESSURE OR INERT GAS
CHEMICAL DISINFECTANT FORMALIN
67. TEST FOR PLASTIC CONTAINERS
LEAKAGE TEST
WATER PERMEABILITY
TEST
COLLAPSIBILITY TEST
CLARITY TEST
BIOLOGICAL TOXICITY TEST
68. ADVANTAGES OF PLASTIC
CONTAINERS
THEY ARE LIGHT IN WEIGHT AND
CAN BE HANDLED EASILY.
THEY ARE TRANSPORTED EASILY.
THEY ARE UNBREAKABLE.
THEY ARE AVAILABLE IN VARIOUS
SHAPES AND SIZES.
THEY ARE RESISTANCE TO VARIOUS
CHEMICALS.
69. DISADVANTAGES OF PLASTIC CONTAINERS
1) THEY ARE PERMEABLE TO
WATER VAPOUR AND
ATMOSPHERIC GASES.
2) THEY ARE POOR CONDUCTOR
TO HEAT.
3) THEY MAY ABSORB CHEMICAL
SUBSTANCE SUCH AS
PRESERVATIVES OF THE
SOLUTION.
4) THEY ARE RELATIVELY
70.
71. METAL CONTAINERS
METALS ARE USED FOR THE CONSTRUCTION OF
CONTAINERS.
ADVANTAGES:-
THEY ARE IMPERMEABLE TO LIGHT, MOISTURE AND
GASES.
THEY ARE MADE INTO RIGID UNBREAKABLE CONTAINERS
BY IMPACT EXTRUSION.
THEY ARE LIGHT IN WEIGHT.
DISADVANTAGES:-
THEY ARE EXPENSIVE.
THEY REACT WITH CERTAIN CHEMICALS.
72. THESE METAL CONTAINERS ARE
PREPARED BY USING DIFFERENT METALS:
ALUMINIUM
ALUMINIUM FOIL
TIN
LEAD
STAINLESS STEEL
73. METAL COLLAPSABLE TUBES
TIN ALUMINIUM LEAD
1) MOST EXPENSIVE 1) LIGHT IN WEIGHT 1)CHEAPER THAN
OTHER 2)MOST CHEMICALLY 2) PROVIDES ATTRACTIVNESS
MATERIALS
INERT OF ALL METALS OF TIN AT LOW COST 2)SHOULD NEVER
USED
COLLAPSABLE TUBES ALONE FOR
ANYTHING
TAKEN INTERNALLY
BECAUSE OF
CHANCES
OF LEAD
POISONING.
74. ALUMINIUM
IT IS ABLE TO RESIST THE CORROSION .
ALUMINIUM TUBES OFFER SIGNIFIGANT SAVINGS IN
PRODUCUT SHIPPING COST BECAUSE OF THEIR LIGHT
WEIGHT.
THEY ARE ATTRACTIVE IN NATURE.
ALUMINIUM FOIL:
IT IS ALSO CALLED Al-FOIL.
IT IS ALSO CALLED TIN FOIL BUT IT IS NOT MADE FROM TIN.
75. TIN:
MOST EXPENSIVE AND CAN BE HIGHLY POLISHED .
IT IS USED AS APROTECTIVE COAL FOR OTHER METALS IN
ORDER TO PREVENT CORROSION OR CHEMICAL REACTIONS.
TIN CONTAINERS ARE PREFERRED FOR FOOD
,PHARMACEUTICALS AND ANY PRODUCT FOR WHICH PURITY
IS CONSIDERED.
76. LEAD:
LEAD HAS THE LOWEST COST OF ALL TUBE METALS AND IS
WIDELY USED FOR NON FOOD PRODUCTS SUCH AS
ADHESIVES, INK, PAINT AND LUBRICANTS.
LEAD SHOULD NEVER BE USED ALONE FOR ANYTHING TAKEN
INTERNALY BECAUSE OF THE RISK LEAD POISON.
77. STAINLESS STEEL:
CHROMIUM - 12 TO 14 PERCENT.
NICKEL – UPTO 0.7 PERCENT ARE
WIDELY USED FOR MANUFACTURING
OF EQUIPMENTS.
78. COLLAPSABLE METAL TUBE
ADVANTAGES:
IT IS AN ATTRACTIVE CONTAINER THAT
PERMITS CONTROLLED AMOUNT TO BE
DESPENSED EASILY WITH ADIQUATE
PRODUCTION OF PRODUCT USUALLY MADE
UP OF ALUMINIUM, LEAD AND TIN METALS.
IF PRODUCT IS INCOMPATIBLE WITH BASE
METAL THAN INTERIOR SURFACE IS
COATED WITH WAX OR LACQUER.
THESE ARE LIGHT IN WEIGHT AND
UNBREAKABLE.
81. RUBBER
RUBBER IS USED IN MANUFACTURE OF CLOSURES, CAPS
, VIALS WRAPPERS AND PLUNGERS.
CLOSURES IS A DEVICE TIGHTLY PACK THE CONTAINER
TO EXCLUDE OXYGEN, CARBONDIOXIDE, MOITURE , AND
MICRO-ORGANISM AND PREVENT THE LOSS OF WATER
AND VOLATILE SUBSTANCES FROM THE PRODUCT
DURING TRANSPORT AND HANDLING.
IT IS A PART OF CONTAINERS SYSTEM BUT COME IN
CONTACT WITH DRUG.
84. DEFINITION
OPHTHALMIC PREPARATIONS ARE SPECIALIZED
DOSAGE FORMS DESIGNED TO BE INSTILLED ONTO THE
EXTERNAL SURFACE ON THE EYE , ADMINISTRETED INSIDE OR
ADJACEMENT TO THE EYE OR USED IN CONJUCTION WITH AN
OPHTHALMIC DEVICE.
85. CONTAINERS USED FOR
OPTHALMIC AND PARENTERAL
PREPARATIONS.
OPHTHALMIC PRODUCTS HAVE SEVERAL TYEPS i.e.,
EYE DROPS
EYE LOTIONS
EYE OINTMENTS
EYE CREAMS
EYE GELS
CONTACT LENS SOLUTION
PARENTERAL PRODUCTS
OPHTHALMIC INSERTS
POWDERS
87. PACKAGING OF OPHTHALMIC
PREPARATIONS
EYE DROPS (MULTIPLE DOSE CONTAINERS):
TRADITIONALLY, GLASS BOTTLES WITH
RUBBER DROPPER WERE WIDELY USED (LDPE) ARE
WIDELY USED.
89. PACKAGING OF OPHTHALMIC
PREPARATIONS
CURRENTLY ALMOST ALL COMMERCIALLY AVAILABLE
OPHTHALMIC PRODUCTS ARE PACKAGED IN PLASTIC
CONTAINERS.
ADVANTAGES:-
EASY OR USE .
LESS SPILAGE.
LESS BREAKAGE.
THE PLASTIC BOTTLES FOR PACKAGING OF OPHTHALMIC
PRODUCTS ARE GENERALLY MADE OF :-
LOW DENSITY POLYETHYLENE (LDPE).
POLYPROPYLENE (PP).
HIGH DENSITY POLYETHYLENE (HDPE).
90. PACKAGING OF OPHTHALMIC
PREPARATIONS
PARENTERAL DOSAGE FORMS DIFFER
FROM ALL OTHER DOSAGE FORMS
BECAUSE THEY ARE INJECTED DIRECTLY
INTO BODY TISSUE THROUGH THE
PRIMARY PROTECTED SYSTEM OF THE
HUMAN BODY , THE SKIN AND THE
MUCOUS MEMBRANES.
THEY MUST BE EXCEPTIONALLY PURE AND
FREE FROM PHYSICAL , CHEMICAL AND
BIOLOGICAL CONTAMINANTS.
91. THESE REQUIREMENTS PLACE A
HEAVY RESPONSIBLE ON THE
PHARMACEUTICAL INDUSTRY TO
PRACTICE CURRENT GOOD
MANUFACTURING PRACTICES IN THE
MANUFACTURING AND PACKAGING
OF DOSAGE FORMS.
CONTAINERS FOR AQUEOUS
PARENTERAL PREPARATIONS ARE
TESTED FOR ARSENIC RELEASE AND
COLOURED GLASS CONTAINERS ARE
TESTED FOR SPRECTRAL
TRANSMISSION.
92. CONTAINERS USED FOR
PARENTERAL PRODUCTS
SMALL VOLUME PARENTERALS
PRODUCT CONTAINERS (VOLUME
UPTO 100ml)
SINGLE DOSE CONTAINERS :-
AMPOULE
MULTI DOSE CONTAINERS :- VAILS
PRE FILLED SYRINGE
LARGE VOLUME PARENTERALS
PRODUCT CONTAINERS
GLASS BOTTLES
PVC COLLAPSABLE BAGS
93. AMPOULES
A PARENTERAL PRODUCT CONTAINER MADE ENTIRELY OF
GLASS AND INTENDED FOR SINGLE USE.
THE AMPOUES CAN BE BROKEN AT THE NECK
RESTRICTION EITHER BY SCORING OR BY HAVING A
CERAMIC POINT BAKED ON DURING THE MANUFACTURE
THUS CAUSING A WEAK PIONT.
94. VIALS
A GLASS OR PLASTIC CONTAINER CLOSED WITH AN
ALUMINIUM CRIMP .
VIALS ARE AVAILABLE FOR SINGLE OR FOR
MULTIPLE DOSING .
INJECTION VIALS CAN BE OBTAINED IN EITHER
NEUTRAL OR SODA GLASS AND OCASIONALLY IN
TREATED SODA GLASS.
95. HDPE PLASTIC VIALS TYPE 1 GLASS
VIALS
FOR MULTI
DOSING
PURPOSE
97. TESTING FOR CONTAINERS
FOR GLASS
POWDER GLASS TEST
WATER ATTACK TEST
LIGHT TRANSMISSED TEST
FOR PLASTIC
LEAKAGE TEST
PERMEATION TEST
COLLAPSIBILITY TEST
TEST FOR CLARITY OF AQUEOUS EXTRACT etc.,
BIOLOGICAL TESTING
98. EVALUATION OF PACKAGING
MATERIAL
TESTS FOR GLASS CONTAINERS
1) POWERED GLASS TEST
2) WATER ATTACK TEST
PREPARATION OF SPECIMEN FOR POWDERED GLASS
TEST:-
RINCE 6 OR MORE CONTAINERS AND DRY THEM
CRUSED INTO FRAGMENTS
DIVIDE 100 gm OF COARSELY CRUSHED GLASS
INTO THREE EQUAL PARTS
99. PLACE 1 PORTION IN A MORTAR
CRUSH FURTHER BY STRIKING 3 OR 4 BLOWS WITH HAMMER
NEST THE SIEVES (# 20 , 40 AT LEAST)
EMPTY THE MORTAR IN TO SIEVE 20
SHAKE THE SIEVES AND REMOVE THE GLASS PARTICLES FROM
#20 AND 40
CRUSH THEM AGAIN AND SIEVE THEM
TRANSFER THE RETAINED PORTION ON #50
100. SPREAD THE SPECIMEN ON A GLAZED PAPER AND REMOVE
IRON PARTICLES WITH THE HELP OF MAGENT
WASH WITH 6 PORTION OF 30ML ACETONE
DRY THE CONTENTS FOR 20 MINS AT 140 DEGREE
CELSIUS
TRANSFER TO WEIGHING BOTTLE AND COOL IN A
DESICCATOR
FINAL SPECIMAN SHOULD BE USED IN POWDERED GLASS
TEST
101. POWERED GLASS TEST:
(ACCORDING TO USP VOLUME 27)
TRANSFER 10GMS OF PREPARED SPECIMEN IN A 250ML
CONICAL FLASK DIGESTED PREVIOUSLY WITH HIGH PURITY
WATER IN A BATH AT 90 DEGREE CELSIUS.
ADD TO CONICAL FLASK CONTAINING 50ML HIGH PURITY
WATER
CAP ALL THE FLASKS AND AUTO CLAVE
ADJUST THEMPERATURE TO 150 DEGREE CELSIUS
COLD THE TEMPERATURE TO 121 DEGREE CELSIUS FOR 30
MINS
COOL THE FLASKS UNDER RUNNING WATER
102. WASH THE POWDERED GLASS (4 TIMES WITH 15ML PURITY
WATER)
ADD THE DECANTED WASHINGS MAIN PORTION
ADD FIVE DROPS OF METHYL RED SOLUTION
TITRATE IMMEDIATELY WITH 0.02N SULPURIC ACID
RECORD THE VOLUME OF 0.02N SULPURIC ACID
VOLUME DOSE NOT EXCEED i.e., INDICATED IN THE USP AS PER
THE TYPE OF GLASS CONCERNED
103. WATER ATTACK TEST: (USP)
RINSE 3 OR MORE CONTAINERS WITH HIGH PURITY WATER
FILL EACH CONTAINERS TO 90% OF ITS OVER FLOW
CAPACITY
CAP ALL THE FLASKS AND AUTOACTIVE FOR 60 MINTS
EMPTY THE CONTENTS AND COOL THE CONTENTS IN 250ML
CONICAL FLASKS TO A VOLUME OF 100ML
ADD 5 DROPS OF METHYL RED SOLUTION
TITRATE WITH 0.02N SULPURIC ACID WHILE WARM
RECORD THE VOLUME OF 0.02N SULPURIC ACID CONSUMED
VOLUME SHOULD NOT EXCEED AS INDICATED IN DSP AS FOR
TYPES OF GLASS
104. TESTS FOR PLASTIC CONTAINERS
1. LEAKAGE TEST FOR PLASTIC CONTAINERS(NON
INJECTABLES AND INJECTABLES 1996 IP)
FILL 10 PLASTIC CONTAINERS WITH WATER AND FIT THE
CLOSURE
KEEP THEM INVERTED AT ROOM TEMPERATURE FOR 24
HRS
NON SIGN OF LEAKAGE SHOULD BE THERE FROM ANY
CONTAINER
105. 2.WATER PERMEABILITY TEST FOR PLASTIC CONTAINERS
(INJECTABLE PREPARATIONS IP 1996):
FILL 5 CONTAINERS WITH NOMINAL VOLUME OF WATER AND
SEALED
WEIGH EACH CONTAINER
ALLOW TO STAND FOR 14 DAYS AT RELATIVE HUMIDITY OF
60% AT 20-250 DEGREE CELCIUS
106. 3. CLARITY TEST
TEST IS APPLICABLE TO CONTAINERS OF ORAL
LIQUIDS , UNLABELLED , UNMARKED PORTION FROM
SUITABLE CONTAINERS ARE RANDOMLY SELECTED.
THESE PORTION ARE CUT INTO STRIPS AND
WASHED TWICE WITH DISTILLED WATER FOR 30sec
AND THEN WATER IS DRAINED. STRIPS ARE
TRANSFERRED TO A CLEAN FLASK (PREVIOUSLY
WASHED WITH CHROMIC ACID & WATER) . ADDED
250ml OF DISTILLED WATER THE FLAK IS COVERED &
AUTOCLAVED FOR 30 min AT 120 DEGREE CELSIUS.
INFERENCE – EXTRACTS CONTENT ARE COOLED &
EXAMINED IT SHOULD BE COLORLES & FREE FROM
TURBIDITY.
107. 4.BIOLOGICAL TOXICITY TEST
INVITRO TEST- EXTRACT PLACED
IN CONTACT WITH MAMMALIAN
CELLS TO CHECK TO TOXICITY.
INVIVO TEST-
SYSTEMIC INJ, TEST- MICE
INTRACUTANEOUS INJ, - RABBIT
IMPLANTATION TEST& EYE
IRRITATION TEST- RABBIT
108. FEATURE ENSURING QUALITY
PROTECTION:
o A CONTAINER INTENTED TO
PROVIDE PROTECTION FROM LIGHT ,
OR OFFERED AS ALIGHT RESISTANT
MUST MEET THE REQUIREMENT OF
THE USP LIGHT TRANSMISSION TEST.
o THE ABILITY OF A CONTAINER TO
PROTECT AGAINST MOISTURE CAN
BE IDENTIFIED BY PERFORMING THE
USP WATER VAPOUR PERMEATION
TEST.
109. COMPATIBILITY:
CONTAINER COMPONENT WILL NOT
INTERACT WITH THE DOSAGE FORM
& MAY NOT SHOW LEACHING.
OTHER CHANGES SUCH AS PH
SHIFT,PRECIPITATION ,
DISCOLORATION SHOULD BE
EVALUATED.
SAFETY:
PACKAGING COMPONENTS SHOULD
BE CONSTRUCTED OF MATERIAL
THAT WILL NOT LEACH HARMFUL OR
UNDESIRABLE AMOUNTS OF
SUBSTANCES.
110. PLAIN
CAP TYPE
CONTINUOUS
PLUG TYPE THREADED
GROWN TYPE LUGGED
CLASIFICATION ROLL ON
PILTER PROOF
SPECIAL TYPE TAMPER
EVIDENT
OVER CAP CHILD
RESISTANCE
111. CONTENT:
INTRODUCTION
PURPOSE OF CLOSURES
CLASSIFICATION OF CLOSURES
MATERIAL EMPLOYED FOR FORMATION OF
CLOSURES
QUALITY CONTROL OF CLOSURES
1.TEST FOR ALKALINITY
2.TURBIDITY TEST
3.FOR RUBBER CLOSURE
4.CHILD TEST
112. PURPOSE OF CLOSURES
RETAINS THE CONTENTS.
PROVIDES A BARRIER TO DIRT, OXYGEN, MOISTURE,
ETC
KEEPS THE PRODUCT SECURE FROM UNDESIRED
AND PREMATURE OPENING.
PROVIDES A MEANS OF RECLOSING OR REUSING
THE CONTAINER.
ASSISTS IN DISPENSING AND USING OF PRODUCT.
MINIMIZES THE EFFECT OF CHANGE OF
SURROUNDINGS OF RELATIVE HUMIDITY, TEMP ,OR
PRESSURE.
PROVIDES A TOTALLY HERMETIC SEAL. THIS IS A
CLOSURE THAT PERMITS NO EXCHANGE B/W THE
CONTENTS AND OUTSIDE OF THE PACK.
113.
114. 1.CAP TYPE
IN THIS FORM, CLOSURE IS AN EXTERNAL CAP THE NECK.
THESE ARE USED TO SECURE THE CLOSURE TO THE
CONTAINER IN ORDER TO MAINTAIN THE INTEGRITY OF
HANDLING AND STORAGE.
115. PLAIN OR SNAP FIT:
IN THIS THE CAP IS PRESSED TO SEAL.
IT CLOSES WITH A CLICK.
CAN BE APPLIED VERY QUICKLY.
116. THREADED OR SCREW CAP:
IT IS A MECHANICAL DEVICE WHICH IS SCREWED ON AND
OFF A CONTAINER.
EITHER CONTINUOUS THREADS OR LUGS ARE USED.
IT MUST BE ENGINEERED TO BE COST EFFECTIVE.
PROVIDE AN EFFECTIVE SEAL.
COMPLIES WITH THE CONTENTS.
COMPILES WITH PRODUCT, PACKAGE, ENVIRONMENTAL
LAWS AND REGULATIONS.
117. SCREW CAP CONSISTS OF 3 COMPONENTS:
1. CAP
2. WAD
3. LINER
CAP:
o MAY BE OF METAL,USUALLY TIN PLATE OR ALUMINIUM OR
MAY ALSO BE A PLASTIC MATERIAL WHICH MAY BE OF
THERMOSETTING TYPE(FOR MORE RIGIDITY).
o PLASTIC CAPS ARE MORE BENEFICIAL AS CAPABLE OF
RESISTING CORROSION & DO NOT CONTAMINATE THE
PRODUCT.
118. WAD:
IT SHOULD BE EFFECTIVE TO PROVIDE
SATISFACTORY SEAL AND INERT TO AVOID
CONTAMINATION OF THE PRODUCT.
SILICON RUBBER CAN BE USED BUT IN
PRACTICE WADS ARE COMMONLY OF
CORK COMPOSITION.
LINER:
• MUST BE INERT.MATERIAL THAT ARE USED
INCLUDE METAL FOILS, PLASTIC FILMS,
RUBBER OR PAPER IMPREGNATED WITH A
SUITABLE RESIN, WAX OR PLASTIC.
119. CONTINUOUS:
WHEN CAP IS APPLIED , ITS THREAD ARE ENGAGED
WITH THE CORRESPONDING THREADS MOLDED ON
THE NECK OF THE BOTTLE.
FOR OPENING, CLOSURE IS ROTATED.
120. LUGGED:
• SIMILAR TO THE THREADED SCREW CAP
AND OPERATES ON THE SAME PRINCIPLE.
• IT IS SIMPLY AN INTERRUPTED THREAD ON
THE GLASS FINISH , INSTEAD OF A
CONTINUOUS THREAD.IT REQUIRES ONLY
1/4TH ROTATING.
121. 2. PLUG TYPE
IT IS A PUSH FIT INTO THE NECK OF THE
CONTAINER.
Eg. CORK OR GLASS STOPPER,BUT BOTH OF
THESE HAVE BEEN REPLACED BY PLASTIC
STOPPERS.
122. 3.CROWN CAP
THESE ARE SHALLOW METAL CAPS THAT ARE CRIMPED
INTO LOCKING POSITION AROUND THE HEAD OF THE
BOTTLE. GENERALLY MADE UP OF TIN.
123. 4.ROLL ON
REQUIRES A MATERIAL THAT IS EASY TO FORM.
THE ROLL ON CAPS CAN BE SEALED SECURELY, OPENED
EASILY AND RECLOSED EFFECTIVELY.
124. 5. PILFER PROOF
IT IS SIMILAR TO ROLL ON CLOSURE BUT HAS A GREATER
SKIRT LENGTH.
THIS ADDITIONAL LENGTH EXTENDS BELOW THE
THREADED PORTION AND FASTENS TO THE BASIC CAP
BY THE SERIES OF NARROW BRIDGES.
WHEN THE CLOSURE IS REMOVED THE EXTRA PORTION
REMAINS IN THE SPACE ON NECK OF THE CONTAINER.
THE USER CAN RESEAL THE CLOSURE BUT THE
DETACHED BOND INDICATES THAT THE PACKAGE HAS
BEEN OPENED.
125. 6. OVER CAP
THESE ARE ADDITIONAL CLOSURES FOR SIMPLE DOSE
MEASUREMENT.
126. 7. SPECIAL TYPES
TAMPER EVIDENT:
HAVING AN INDICATOR OR BARRIER TO
ENTRY WHICH, IF MISSING,CAN
REASONABLY BE EXPECTED TO PROVIDE
VISIBLE EVIDENCE TO PROVIDE VISIBLE
EVIDENCE TO CONSUMERS THAT
TAMPERING HAS OCCURRED.
A TAMPER EVIDENT PACKAGE MAY INVOLVE
SYSTEMS INTENDED TO PROVIDE A VISIBLE
INDICATION OF PACKAGE INTEGRITY.
127. THESE ARE DESIGNED TO PREVENT
ACCIDENTS AND MALICIOUS
TAMPERING TO CREATE SAFE
PACKAGING.
EACH RETAIL PACKAGE IS REQUIRED
TO CONTAIN A STATEMENT THAT
CONSUMERS ARE ALTERED TO THE
SPECIFIC TAMPER-RESISTANT
FEATURE OF THE PACKAGE.
LABELLING STATEMENT IS REQUIRED
TO BE SO PLACED THAT IT WILL BE
UNAFFECTED IF THE TAMPER-
RESISTANCE FEATURE OF PACKAGE
IS MISSING.
128. VARIOUS TYPES OF TAMPER
EVIDENT PACKAGING
BREAKING CAP RING SYSYTEMS
SEALED TUBES
HEAT SEALED BANDS OR
WRAPPERS
INNER MOUTH SEALS
TAPE SEALS
AEROSOL CONTAINERS
METAL AND COMOSITE CANS
129. BREAKABLE CAPS:
CAP OR PART OF IT MUST BE BROKEN IN
ORDER TO OPEN THE CONTAINER AND
REMOVE THE PRODUCT.
IT MUST NOT BE POSSIBLE TO REPLACE
IT IN ITS ORIGINAL STATE.
130. SEALED METAL TUBES , PLASTIC HEAT SEALED TUBES:
MUST BE HAVE BOTH ENDS SEALED.
MOUTH HAS TO BE PUNTURED TO GAIN ACCESS TO THE
PRODUCT.
CRIMPED ENDS ARE ONLY ACCEPTABLE IF THEY CAN’T
BE UNFOLDED WITHOUT VISIBLE DAMANGED.
131. HEAT SEALED BANDS OR WRAPPERS :-
o MUST BE PLACED OVER THE UNION
OF PRIMARY CLOSURES (CAP, LID ,etc.,
)AND CONTAINER.
o MUST HAVE A DISTINCTIVE DESIGN.
o MUST GET SHRUNK BY HEAT.
o MUST BE CUT OR TORN TO GAVE
ACCESS.
o MUST NOT BE WORKED OFF WITHOUT
LEAVING VISIBLE EVIDENCE.
o A PERFORATED TEAR STRIP
ENHANCES TAMPER EVIDENCE.
132. INNER SEALS:
WHETHER MADE OF PAPER
,PLASTIC FILM , FOIL OR
COMBINATIONS ,THEY MUST
HAVE A DISTINCTIVE DESIGN.
MUST BE TORN OR BROKEN TO
GAIN ACCESS.
HEAT INDUCTION SEALS ARE
ARE CONSIDERED SUPERIOR TO
ADHESIVE SEALS.
133. TAPE SEALS :
INVOLVES THE APPLICATION OF A GLUED OR PRESSURE
SENSITIVE TAPE OR LABEL AROUND OR OVER THE
CLOSURE OF THE PACKAGE ,WHICH MUST BE
DESTROYED TO GAIN ACCESS TO THE PACKAGED
PRODUCT.
IF USED ON CARTONS THEY MUST BE APPLIED OVER
ALL FLAPS.
134. AEROSOLS
CONSIDERED TO BE INHETENTLY TAMPER
RESISTANT.
DIRECT PRINTING ON THE CONTAINER IS
PREFERABLE TO A PAPER LABEL.
135. CANS AND COMPOSITE
CONTAINERS
TOP AND BOTTOM OF A COMPOSITE MUST BE JOINT TO
THE WALLS SO THAT THEY CAN’T BE PULLED APART AND
REPLACED.
136. CHILD RESISTANCE
THESE ARE DIFFICULT FOR YOUNG CHILDREN (UNDER 5
YEARS OF AGE ) TO OPEN BUT NOT DIFFICULT FOR
ADULTS TO USE PROPERTY.
THESE HAVE BEEN PRODUCED IN RESPONSE TO
DEMAND FOR GREATER PROTECTION OF CHILDREN
AGAINST ACCIDENTAL POISONING.
USED FOR DRUGS ,HOUSE CLEANSING AGENTS
,PESTICIDES,etc.,
137. DESIGN OF CHILD RESISTANCE
CLOSURES
PRESS AND TURN
LIFT AND TURN
SQUEEZE AND TURN
LINE UP ARROWS AND FLIP
POP LOCK CLOSURE
138. PRESS AND TURN
THE CAP IS REMOVED BY APPLYING A DOWNWARD
PRESSURE WHILE THE CLOSURE IS ROTATED.
CLICK LOCK :-
CLOSURE IS ONE OF THE MOST SUCCESSFUL
OF THIS TYPE. IT IS ALSO INCORPORATE A FORMS OF
ALARM FOR AN ADULT IN THAT IF THE CAP IS TURNED
WITHOUT PRESSING THEN A CLICKING SOUND IS DEARD.
139. LIFT AND TURN
IT INVOLVES APPLYING AN UPWARD FORCE ROTATING
THE CLOSURE.
SQUEEZE AND TURN
FORCE IS APPLIED TO THE SIDES OF THE CLOSURE
WHILE THE SIDES OF THE CLOSURE WHILE THE SCREW
CAP IS ROTATED.
140. LINE UP ARROWS AND FLIP
ONCE THE ALIGNMENT IS ESTABLISHED THE MISS –FIT
BETWEEN CAP AND CONTAINER IS REMOVED AND THE
CAP WILL LIFT.
POP LOCK CLOSURES
CAN ONLY BE OPERATED AFTER A TAB ON ITS TOP HAS
BEEN RELEASED AND THEN OPENING IS ACHIEVED BY
PULLING ON IT.
142. METAL
METAL CAPS ARE USUALLY COATED
ON THE INSIDE WITH AN ENAMEL
FOR RESISTANCE AGAINST
CORROSION.
ALMOST ALL METAL CROWNS AND
CLOSURES ARE MADE FROM
ELECTROLYTE TINPLATE , A TIN
COATED STEEL ON WHICH THE TIN
IS APPLIED BY ELECTROLYTIC
DEPOSITION .
TIN IS MOST CHEMICAL INERT.
143. PLASTIC
THE TWO BASIC TYPES OF PLASTIC OF PLASTIC
GENERALLY USED FOR CLOSURES ARE:
THERMOSETTING RESINS:
IS USED FOR MAKING SCREW CAPS FOR GLASS
AND METAL CONTAINERS.
THE THERMOSETTING PLASTIC FIRST SOFTENS
UNDER HEAT AND THEN CURES AND HARDENS TO
A FINAL STATE.
THERMOPLASTIC RESINS:
POLYSTERENE ,POLYETHYLENE AND
POLYPROPYLENES ARE THE MATERIALS USED IN 90
PERCENT OR MORE OF ALL THERMOPLASTIC
CLOSTURES.
144. ADVANTAGES OF PLASTIC
1) FLEXIBLE AND NOT EASILY BROKEN.
2) LOW DENSITY AND THUS LIGHT IN WEIGHT.
3) EASILY MOULDED IN VARIOUS SHAPES.
4) CHEAP.
LIMITATIONS:-
NOT CHEMICALLY INERT .
UNDERGO STRESS CRACKING AND DISTORTION FROM
CONTACT WITH SOME CHEMICALS.
NOT HEAT SENSITIVE.
MAY POSSESS AN ELECTROSTATIC CHARGE AND WILL
ATTRACT PARTICALS.
145. RUBBER CLOSURES
RUBBER CONSISTS OF
SEVERAL INGREDENTS , ONE
OF THEM IS ELASTOMER.
THESE CLOSURES DO NOT
POSE A PROBLEM AND CAN
BE USED IN CONTACT WITH
LARGE NUMBER OF DRUG
PREPARATIONS.
146. TYPES OF RUBBER USED IN
PHARMACEUTICALS
1) BUTYL RUBBER
2) NITRILE RUBBER
3) NEOPRENE RUBBER
4) SILICON RUBBER
147. BUTYL RUBBER :- CHEAP , CHEMICAL
RESISTANCE , LOW WATER VAPOUR OR AIR IG.
IT IS NOT GOOD FOR OILS.
NITRILE RUBBER :- RESISTANT TO OIL , HEAT
TREATMENT ,VAPOUR ABSORPTION BUT
LEACHING AND BACTERICIDE ABSORPTION IS
HIGH.
NEOPRENE RUBBER:- RESISTANT TO HEAT AND
OIL WITH LOW WATER ABSORPTION
PERMEABILITY AS COMPARED TO NATURAL
RUBBERS.
SILICON RUBBER :- MOST HEAT RESISTANT
ABOUT 250 DEGREE CELSIUS WITH VERY LOW
WATER ABSORPTION AND PERMEABILITY , BUT
148. TYPES OF RUBBER
CLOSURES
COMMON FLANGED CLOSURE.
SLOTTED OR FREEZE DREID PRODUCT CLOSURE.
CARTILAGE AND DISPOSABLE SYRINGE CLOSURE.
150. SLOTTED OR FREEZE DRIED PRODUCT
CLOSURE
THESE CLOSURES HAS A SLOT OR PATHWAY FOR THE
ICE SUBLIMATION.
USED TO SEAL THE FREEZE DRIED PRODUCTS OR
LYOPHILIZED PRODUCTS.
151. CARTILAGE AND DISPOSAL
SYRINGE CLOSURE
CARTILAGE IS MADE OF GLASS ,ONE END OF WHICH IS
SEALED WITH THE RUBBER PISTON AND THE OTHER
END WITH ALUMINIUM OVER SEAL AND RUBBER SEPTUM.
152. CHARACTERISTIC OF IDEAL
RUBBER CLOSURE
IT SHOULD NOT BECOME STICKLY UPON STORAGE .
IT SHOULD NOT BECOME HARD ON EXPOSURE TO
ATMOSPHERE.
IT SHOULD NOT BECOME DARK ON EXPOSURE TO AIR
AND LIGHT .
EASE IN PENETRABILITY AND ELASTICITY(IN CASE OF
VIALS).
EASE INSTERLIZATION-RUBBER CLOSURE MUST WITHSTAND
HEAT ATLEAST ABOUT 120 DEGREE CELSIUS.
IT MUST NOT BECOME STICKLY DURING AUTO CLAVING.
IT SHOULD NOT ALLOW WATERVAPOUR AND AIR TO PASS
THROUGH IT.
IT SHOULD BE FREE FROM LEACHING AND SORPTION.
153. QUALITY CONTROL OF CLOSURES
TEST FOR ALKALINITY (FOR GLASS )
TEST FOR RUBBER CLOSURES:
a) COMPATIBILITY WITH CONTENTS
b) PERMEABILITY TO WATER
c) SELF SEALABILITY
d) FRAGMENTATION
e) PENETEABILITY
f) QUALITY
g) FINISH TEST
CHILD TEST
154. TEST FOR ALKALINITY
COARSELY CRUSH THE GLASS AND THEN CRUSH FINELY.
SIEVE THE CRUSHED GLASS .
TAKE 2 CONICAL FLASK , ONE SHOULD BE TREATED AS
‘BLANK’ WHILE OTHER AS ‘SAMPLE CONTAINER.
PUT THE CONICAL FLASK AND CONSIDER AS SAMPLE
CONTAINER.
ADD SOME DISTILLED WATER IN BOTH OF THE FLASK.
CLOSE BOTH THE FLASK WITH CLOSURE.
AUTOCLAVE BOTH FOR PRESCRIBED PERIOD OF TIME.
ADD NaOH SOLUTION AND WASH WITH WATER.
FILTER THE SOLUTION AND WASH WITH WATER.
TITRATE THE FILTRATE WITH STANDARD NORMAL ACID.
CALCULATE THE NORMALITY OF ALKALI AND THEN THE
CONCENTRATION IS CALCULATED .
THE CONCENTRATION OF ALKALI SHOULD NOT EXCEED THE
PRESCRIBED LIMIT.
155. TEST FOR RUBBER CLOSURES
a. COMPATIBILITY WITH OTHER COMPONENTS:-
ALL THE STERILE PRODUCTS ARE PACKED
ASEPTICALLY IN STERILE CONTAINERS AND SEVERAL ARE
STORED UNDER DIFFERENT CONDITIONS.AT GIVEN TIME
INTERVAL UP TO A YEAR , EXCEPT FOR THE 50 DEGREE
CELSIUS TEST , WHICH ARE CONTINUED FOR 3 MONTHS ONLY
, THE SAMPLES ARE EXAMINED FOR ---
FOREIGN INSOLUBLE MATTER ,USING STANDARD CONDITION
OF ILLUMINATION.
LOSS OF POTENCY AND PRESERVATIVES AND INCREASE IN
TOXICITY.
SIGNS OF DETERIORATION OF THE CLOSURE , SUCH AS
SPONGINESS AND DISCOLOURATION.
THE LATTER SHOULD BE CHECKED AFTER DRYING
OVERNIGHT BECAUSE ABSORPTION OF WATER AND CERTAIN
SOLUTES OFTEN PRODUCES A BLEACHED APPEARANCE .
156. B. PERMEABILITY TO WATER
PUT CALCIUM CHLORIDE IN VIALS AND CLOSE IT WITH
RUBBER CLOSURE AND SEAL IT WITH ALUMINIUM SEAL.
WEIGH THE VIAL
PLACE IT FOR A LIMITED
WEIGH AGAIN
IF WEIGH NOTED DOWN LATER IS MORE THAN PREVIOUS
THEN TEST FAILS AS WEIGHT IS INCREASED DUE TO
THE ABSORPTION IF WATER VAPOURS.
157. C. SELF SEALABILITY
TAKE A VIALS AND FILLED IT WITH METHYLENE
BLUE SOLUTION
INSERT NEEDLE INTO RUBBER CLOSURE 20-25
TIMES WITHIN A CIRCLE OF 5mm DIAMETER
VIAL IS INVERTED IN WATER IN A CONTAINER
TO WHICH A PRESCRIBED VACUUM IS APPLIED FOR
HALF AN HOUR
THERE MUST BE NO SIGNS OF LEAKAGE IN THE
WATER OR ON THE CLOSURE .
158. D. FRAGMENTATION TEST
TAKE 12 CLEAN VIALS
PLACE A VOLUME OF WATER CORRESPONDING TO NOMIAL
VOLUME -4ml IN EACH
CLOSE VIAL WITH CLOSURE AND SECURE CAPS FOR 16 HOUR
PIERCE THE CLOSURES WITH HYPODERMIC NEEDLE AND INJECT
1ml WATER AND REMOVE 1ml AIR
REPEAT THE ABOVE OPERATION 4 TIMES FOR EACH CLOSURE
COUNT THE NUMBER OF FRAGMENTS VISIBLE TO NAKED EYE
TOTAL NUMBER OF FRAGMENTS SHOULD NOT BE MORE THAN
10 EXCEPT BUTYL RUBBER WHERE THE FRAGMENT SHOULD
NOT EXCEED 15.
159. E.PENETRABILITY TEST (BY
PIERCING MACHINE)
INVERTED VIAL IS FITTED ON CLAMP AND
THE CLAMP IS ALLOW TO MOVE
DOWNWARD AT A SPECILIZED SPEED.
STAND HAVING NEEDLE IS FITTED WITH
PISTON TYPE CYLINDER.
AS CLAMP MOVES DOWNWARD WITH VIAL
NEEDLE WILL GO INSIDE THE VIAL AND
THE PISTON MOVES DOWNWARD.
FORCE APPLIED ON THE VIAL SHUOLD
NOT EXCEED A STATED VALUE.
160. F. QUALITY TEST
RUBBER CLOSURES MUST NOT BE TACKLY AFTER
WASHING IN A DETERGENT , RINSING SEVERAL TIMES ,
AUTOCLAVING FOR HALF AN HOUR AT 121 DEGREE
CELSIUS IN DISTILLED WATER AND DRYING FOR A DAY
AT 65 DEGREE CELSIUS IN VACUUM.
G. FINISH TEST
THEY MUST BE SUBSTANTIALLY FREE FROM
ADVENTITIOUS DUST , FIBERS , LOOSE PARTICALS OF
RUBBER , SMEARS OF GREASE AND PIGMENT, AND QUIT
FREE FROM INTERNAL FOREIGN MATTER.
161. CHILD TEST
200 CHILDREN OF 42-51 MONTHS DIVIDED
APPROXIMATELY EQUALY BETWEEN THE SEXES
AND 100 NORMAL ADULTS BETWEEN 18-65 YEARS
OF AGE [70 FEMALE AND 30 MALE] ARE SELECTED.
TEST INVOLVING CHILDREN MUST BE CARRIED OUT
IN FAMILIAR ENVIRONMENT SUVH AS SCHOOL BUT
THE ADULTS CAN POLLED IN ANY CONENIENT
CENTRE.
CHILDREN OPERATE IN PAIRS UNDER A QUALIFIED
SUPERVISOR.
EACH CHILD IS GIVEN A PACKAGE CONTAINER A
PLACEBO DRUG AND ALLOWED 5 MIN TO TRY AND
OPEN IT.
162. IF THEY ARE UNSUCCESSFUL THEY
RECEIVE A NON- VERBAL DEMONSTRATION
AND A FURTHER 5 MINUTE TO TRY AGAIN.
ADULTS ARE ASKED TO OPEN THE
PACKAGE INDIVITUALLY WITHIN 5 MINUTE
USING ONLY THE DIRECTIONS THAT
APPEAR ON THE PACKAGE ITSELF AND
THEN TO RECLOSE IT PROPERTY IF IT IS
RE-CLOSABLE TYPE .
AFTER THE FULL 10 MINUTE 80 PERCENT
OF THE CHILDREN SHALL NOT SUCCEED
IN OPENING THE PACKAGE AND AFTER 5
MINUNE 90 PERCENT OF THE ADUTS MUST
BE SUCCESSFUL.