1. CONTAINERS, CLOSURES AND
LECTURE
CONTAINERS, CLOSURES AND
THE PACKING MATERIALS
USED IN PHARMACY
Plan of the lecture:
1. Classification of containers.
2. Classification of closures.
3. Packing materials.
4. Requirements to containers, closures and packing materials.
5. Storage of containers, closures and packing materials.

2. Classification of containers
By functional purpose
Consumer (retail)
container
Transport
container
Initial
(immediate)
Secondary
(outer)

3. cardboard, wooden, combined
By turnover
Single-use
Reusable
By materials used
Glass, polymeric, metal,
cardboard, wooden, combined

4. By shape By rigidity Cylindrical conic Round and oval in section
Tetrahedral
containers
of complex design
By rigidity
Rigid
Soft

5. By capacity Consumer (retail) Transport (shipping) Small, average,
large
Small-sized,
large-sized

6. By method of manufacturing
Blown
Stamped
Pressed
Thermoformed
Glued
Moulded

7. Transparent, opaque, white or painted
By volume
Full
Nominal
By color
Transparent, opaque, white or painted

8. By design features Consumer (retail): Transport (shipping):
Vials with ground neck,
jars, bottles, vials,
aerosol cylinders,
tubas, blister packages,
packs, parcels, boxes,
cases, test tubes,
cans
Transport (shipping):
Boxes, barrels, canisters,
drums, cylinders, trays,
cans, baskets, sacks
Folding, nondemountable,
collapsible.
Open, closed,
crate

9. Classification of glass retail containers by way of manufacturing
Produced of glass mass:
Vials with ground neck,
jars, bottles, vials,
aerosol cylinders
Produced of glass rods:
Ampoules, insulin vials
and vials of general
purpose, carpules,
syringes, jars with
triangular
nimbus

10. Classification of retail containers
by design features
Jar - is retail container mainly with cylindrical body, with a mouth which diameter is equal to diameter of a body or slightly less, with flat bottom, having capacity from 0,025 up to 10,0 litres.
Vial – is retail container with flat or concave bottom, with a body of various shape which sharply narrows into a mouth which nimbus diameter is much less than diameter of a body. Mouth is to be sealed with a stopper and/or a cap.
DSTU

11. Classification of retail containers
by design features
Bottle - is retail container mainly with cylindrical body having flat or concave bottom and a narrow mouth, designed for sealing. Wall of a body usually has a measuring scale.
Ampoule - is single-use retail container with cylindrical body with flat or convex bottom and extended mouth, hermetically soldered after filling production therein.
DSTU

12. Classification of retail containers
by design features
Tube – is a single-use retail container with a body providing manual extrusion of inner content, with a narrow mouth, sealed with a cap, and a bottom closed after filling production therein
Tubes
Polymeric
Aluminium
Laminated
DSTU

13. Classifying of closures
By purpose
Without first opening
control
With the first opening
control

14. By design features Covers – closures that being fixed close
a container by the whole
external perimeter of a mouth
Caps - closures, put onto a mouth
of a container after its corking
in order to protect it from
undesirable opening
Tube covers - versions of covers,
screwed onto outlet neck of tubes

15. Stoppers (plugs) - are to be
inserted or screwed inside
mouths of a container
Closures with additional
functional adaptations
(spraying, dosing,
smearing, dispersion)

16. By method of fixing onto container
Screwed
Pulled-on
Rolled-on
Inserted

17. By materials
Glass
Combined
Rubber
Plastic
Cork
Metal

18. By method of sealing and By method of manufacturing
sealing materials
With linings
With germetics
or elastic
materials
Fixed by
welding
or glueing
By method of manufacturing
Stamping
Stretching
Pressing
Moulding
under
pressure

19. Requirements to containers, closures and packing materials
General
Special
Sanitary-
hygienic

20. General requirements Protection from mechanic
and physico-chemical influences
Operational
Package should be easy to open and close;
should provide easy withdrawing
of contents being in any aggregative state;
should be attractive, informative
Consumer
Should provide easy transportation
of goods, application of
automatic sealing equipment;
should have corresponding
sizes providing convenience
in use and compactness
Technological

21. Modern requirements for packing materials and containers
should be permitted for use by National (e.g. Ukrainian) MoH and have corresponding registration certificate !!!;
should conform requirements of the acting normative (reference) documentation;
for manufacturing of package only materials which do not influence stability and pharmacological properties of drugs should be used.

22. Within materials of initial (immediate) containers presence of belowmentioned
agents is prohibited:
- As, heavy metals and other harmful impurities in quantities exceeding those indicated in authorized specifications;
- dyers which can react with a drug;
- cancerogenic substances and toxic components;
- foreign smell;
- damage of surface protections of a container;
- mechanic pollutions;
- microorganisms on surface of a container in quantities exceeding those stated in requirements of the corresponding RD.

23. The design of initial package should provide:
- protection of drugs against influence of environment;
- prevention of mechanic influence;
- tightness and stability;
- reliable protection from microbic contamination;
- dosed or single-unit withdrawing of a drug;
- if necessary, provide the first opening control and safety of a product;
- attractive appearance and convenience in use.

24. In SPhU 1.1 (in EP 5) the following packaging materials are recommended for drugs:
Glass: of 4 grades, depending on hydrolytic resistance
Plastic:
Polyethylene terephtalate
Low density polyethylene
Polypropylene
High density polyethylene
Polyvinylchloride
These materials are recommended by SPhU and EP to use in production of packing for medical products.
Choice of a material depends on properties of a dosage form.
For production of packing for medical products other materials can be also applied, but their application should be authorized by MoH of Ukraine.

25. Technical requirements showed to glass containers
Container should correspond
requirements of State Standards
and Pharmacopoeia of Ukraine
Onto surface and within
glass there should not be:
Chips
Cracks
Chemical and thermal
stability
Seeds
Foreign
inclusions
Surface should
be smooth
Cord,
manually
sensitive
Bruise

26. Technical requirements showed to metal containers (of aluminium)
Internal
surface
should be
covered with
special
varnish
External
surface
should be
enameled
according to RD
Enamel and
printed
paints
should be
water-resistant

27. Technical requirements showed to polymeric containers
Items of plastics should not
have the following defects:
Cracks
Undermoldings
Swellings
Stains
Bowls
Deformations and
joints
Large foreign
inclusions

28. Edges of items should be
Equal,
smooth
Without sharp
sides
No cracks
and agnails
Surface of items
should
correspond
requirements of RD
Materials, used in
manufacturing thereof
should be
harmless

29. Package, marking, shipping
The gross weight of packed place should not
exceed 15 kg. In each box one should put
packing list with indication of:
The enterprise-manufacturer
The name of container or symbol
Date of package
Number of the packer and the controller
of Quality Department
Quantity of items
Number of RD

30. Marking of retail container
According to DSTU 4260:2003 and GOST marking is stamped onto a bottom or onto walls of container near the bottom part of a body.
Marking should contain the following elements:
1. A print of the trademark or code of the enterprise - manufacturer;
2. Nominal capacity (ml / l);
3. Year of manufacture (two last digits);
4. Number of a compression mould (if container is manufactured by method of pressing).
5. Material used in manufacturing of the container

31. In Ukraine in 2004 the Standard DSTU 4260:2003 started
In Ukraine in 2004 the Standard DSTU 4260:2003 started. Тара і паковання спожиткові. Марковання. Загальні вимоги. This one regulates marking of retail container depending on its material.
Moebius loops designating, that the container can be subjected to secondary processing or produced of the recycled raw material. The material is designated by alphabetic symbols and list number.
Material
Al.symbol
Number
polyethylene terephtalate
PET 01
Polythene of high density
HDPE 02
Polyvinyle chloride
PVC 03
Polythene of low density
LDPE 04
Polypropylene PP 05
Polystyrene PS 06
Corrugated cardboard
РАР 20
Material
Al.symbol
Number
Other kinds of a cardboard
РАР 21
Paper 22
Steel FE 40
Aluminium
ALU 41
Tree
FOR 50
Colorless glass GL 70
Brown glass 72

32. Marking of containers of glass rod
Each box is marked with a label,
on which the following info is specified:
The enterprise - manufacturer
The name of an item or symbol
Quantity of items
The following signs are applied:
"cautiously, fragile!"
"not to be tipped!"
“do not throw!"
"top!"

33. Classifying of packing Materials
By purpose
By materials
By types
For powdery,
tabletted,
plastic drugs, etc.
Paper,
cardboard,
polymeric,
metal
(aluminium
foil),
combined
Sheet,
film,
corrugated

34. By way of manufacturing
By quantity of layers
Single-layered
Multilayered
By way of manufacturing
Extrusion
Calendering
Casting
Pressing

35. Assortment of packing materials polyethylene-cellophan
Film
polyethylene (PE)
Film polypropylene
(PP)
Film
polyvinylchloride
(PVC)
Foil
aluminium
varnished
Film
combined
polyethylene-cellophan
(PC)
Paper with
polyethylene
covering
(PPC)

36. Assortment of packing materials
Film
polyamide (PA-1)
Paper
for labels
Three-layer film
of paper, foil,
polyethylene (PFP)
Parchment
(grade B)
Wrapping paper
(grade A and B)
Sub-parchment
(grades ПБ, ПБ-1)

37. Marking of transport containers Handling signs
Basic inscriptions
Additional inscriptions
The name
of consignee
The name of
the sender
The name
destination point
The name of the
departure point
Quantity of cargo
places in a batch
Inscriptions of transport
organizations

38. Storage of containers, closures and packing materials
Store and
transport
only in package
according to RD
Store in dry
aired
premises
Protect from influences of atmospheric
deposits, direct solar beams
and mechanic influences

39. Polymeric containers: at t 10-15◦C, in dry ventilated premises
on distance not less than 1 m
from heating appliances
Glass containers:
in dry aired
premises, protecting
from influence of
atmospheric precipitations
Wooden, cardboard and a paper containers:
at 18-20◦С, protect from humidifying
Metal containers:
protect from corrosion
Rolled packing
materials: store in
vertical position