packing and packaging

Enjoy students of pharmd
specially for uol students

1. Packing and Packaging
Influence of Packaging materials, Stability, Packaging Lines, Packaging Area, Packaging Equipment



The aspects of packaging to be considered (4) include:
1. The functions of packaging
2. The selection of a packaging material
3. The testing of the material selected
4. Filling and Assembling
5. Sterilization
6. Storage and Stability
The quality of the packaging of pharmaceutical products plays a very important role in the quality of such
products. It must:
• protect against all adverse external influences that can alter the properties of the product, e.g. moisture,
light, oxygen and temperature variations
• protect against biological contamination
• protect against physical damage
• carry the correct information and identification of the product.
The kind of packaging and the materials used must be chosen in such a way that:
→the packaging itself does not have an adverse effect on the product (e.g. through chemical reactions, leaching
of packaging materials or absorption)
→the product does not have an adverse effect on the packaging, changing its properties or affecting its protective
function.
Containers for pharmaceuticals
Ampoule
A container sealed by fusion and to be opened exclusively by breaking. The contents are intended for use on one
occasion only.
Packing
Packing consists of enclosing individual items or several items in a container usually for shipment or delivery.
This operation is done by hand or machine.

Packaging
Packaging may be defined as the collection of different components (e.g. bottle, vial, closure, cap, ampoule, and
blister) which surround the pharmaceutical product from the time of production until its use.

INDUSTRIAL PHARMACY

2. Bag
A container consisting of surfaces, whether or not with a flat bottom, made of flexible material, closed at the
bottom and at the sides by sealing; the top may be closed by fusion of the material, depending on the intended
use.
blister
A multi-dose container consisting of two layers, of which one is shaped to contain the individual doses. Strips
are excluded.
Bottle
A container with a more or less pronounced neck and usually a flat bottom.
Cartridge
A container, usually cylindrical, suitable for liquid or solid pharmaceutical dosage forms; generally for use in a
specially designed apparatus (e.g. a prefilled syringe).
Gas cylinder
A container, usually cylindrical, suitable for compressed, liquefied or dissolved gas, fitted with a device to
regulate the spontaneous outflow of gas at atmospheric pressure and room temperature. injection needle
A hollow needle with a locking device intended for the administration of liquid pharmaceutical dosage forms.
Injection syringe
A cylindrical device with a cannula-like nozzle, with or without a fixed needle and a movable piston, used for
the administration, usually parenteral, of an accurately measured quantity of a liquid pharmaceutical form. The
syringe may be prefilled, and can be for single-dose ormulti-dose use
Pressurized container
A container suitable for compressed, liquefied or dissolved gas fitted with a device that, after its actuation,
produces a controlled spontaneous release of the contents at atmospheric pressure and room temperature.
Single-dose container
A container for single doses of solid, semi-solid or liquid preparations. strip
A multi-dose container consisting of two layers, usually provided with perforations, suitable for containing
single doses of solid or semi-solid preparations. Blisters are excluded.
Tube
A container for multi-dose semi-solid pharmaceutical forms consisting of collapsible material; the contents are
released via a nozzle by squeezing the package.

3. vial
A small container for parenteral medicinal products, with a stopper
and overseal; the contents are removed after piercing the stopper.
Both single-dose and multi-dose types exist.
Packaging Materials
Packaging materials include printed material employed in the packaging of a pharmaceutical product, but not
any outer packaging used for transportation or shipment.

Influence of Packaging materials

The pharmaceutical packaging materials contain some important features and functions like: Packaging protect
against all adverse external influence that can alter the properties of the product, Packaging protect against
biological contamination, packaging protect physical damage, packaging carry the correct information and
identification of the Administration. Pharmacopeias various grades of glass are classified as official based on
their chemical characteristics and efficacy within the packaging of pharmaceuticals. Glass containers also are
beneficial from the economical point of view as glass is abundantly present in nature and because of its
capability to be sterilized and hence be recycled. Its distinction when compared to other packaging materials lies
in the unique combination of durability, inertness and transparency. The container chosen for a given preparation
shall be such that the glass material does not release substances in quantities sufficient to affect the stability of
the preparation or to present a risk of toxicity. In justified cases, it may be necessary to have detailed information
on the glass composition, so that the potential hazards can be assessed. The hydrolytic stability of glass
containers for pharmaceutical use is expressed by the resistance to the release of soluble mineral substances into
water under the prescribed conditions of contact between the inner surface of the container or glass grains and
water.
The primary role of packaging, other than its esthetic one, is to protect the dosage forms from moisture and
oxygen present in the atmosphere, light, and other types of exposure, especially if these factors affect the overall
quality of the product on long-term storage. Protection from light can be achieved using primary packaging
(packaging that is in direct contact with the dosage forms) and secondary packaging made of light-resistant
materials. Incorporating oxygen adsorbents such as iron powder in packaging units can reduce the effect of
oxygen. Details on the contributions of packaging to the stability of dosage forms have been extensively
presented elsewhere. This section will emphasize the effect of packaging on moisture adsorption as it affects the
stability of dosage forms and consider the interaction between dosage forms and packaging.
In addition to the labeling and leaflets provided, proper packaging guarantees accurate use of medicinal products.
This promotes compliance and safe administration, as in the case of blister packs indicating which medications
to take at what time. Safety is another component of proper packaging reducing the risk for children in the way
of safety caps. Most importantly, packaging helps users identify correct drugs. Confusion with inadequate
packaging can lead to serious consequences for patients as well as medical professionals.
The impact of packaging on products is great and warrants serious consideration when choosing the right
pharmaceutical products for ophthalmic products.

Containment

4. The containment of the product is the most fundamental function of packaging for medicinal products. The
design of high-quality packaging must take into account both the needs of the product and of the manufacturing
and distribution system. This requires the packaging:
→Not to leak, nor allow diffusion and permeation of the product
→To be strong enough to hold the contents when subjected to normal handling
→Not to be altered by the ingredients of the formulation in its final dosage form
Protection
The packaging must protect the product against all adverse external influences that may affect its quality or
potency, such as:
 light
 moisture
 oxygen
 biological contamination
 Mechanical damage
The compatibility of the packaging with the active pharmaceutical ingredients is very important in maintaining
the integrity of the product.

Stability
Stability of a pharmaceutical product or a drug is defined as “extent to which a product retains, within
specified limits, and throughout its period of storage and use (i-e its shelf life) the same properties and
characteristics that is possessed at the time of its manufacture ~ USP.

Types of Stability
Physical stability
The original physical properties such as appearance, color, dissolution, palatability, suspendability are retained.
The physical stability may affect the uniformity and release rate; hence it is important for the efficacy and safety
of the product.

5. Chemical stability
It is the tendency to resist its change or decomposition due to the reactions that occur due to air, atmosphere,
temperature, etc.
Microbiological stability
The microbiological stability of the drugs is the tendency to resistance to the sterility and microbial growth. The
antimicrobial agents used in the preparation retain the effectiveness. within specified limits. This microbiological
instability could be hazardous to the sterile drug product.
Therapeutic stability
The therapeutic effect (Drug Action) remains unchanged.
Toxicological stability
Toxicological stability has no significant increase in the toxicity occurs.
Stability studies
Stability studies are used for testing the drug product for longer periods under varying conditions of temperature
and Relative Humidity (RH). If the drug is to be distributed in different geographical regions and if shipping is
required for transportation, in that case long term stability studies are of prime importance. Long term stability
studies are performed by testing the sample at specific time intervals and conditions of external parameters are
changed accordingly. Main objective of this study is to determine shelf-life of the drug product. Stability studies
are mainly four types, they are Long term stability, Intermediate stability, Accelerated stability and In-use
stability Studies.
STABILITY TESTING METHODS
Stability testing is a procedure performed for all the pharmaceutical products at various stages of the product
development. In the early stages, the stability testing is performed by the accelerated stability studies which
mainly are performed at high temperature\ humidity. The accelerated stability studies are easy to predict the
degradation of the drug within short period of time. In the accelerated stability studies mainly the drug is
performed at long-term storage. During this elevated temperatures are used to determine the products shelf-life.
The main aim for the stability testing is to provide the acceptance level of fitness/ quality throughout the period
during which they are available for the patience and should be fit for the acceptance of the drug by the patient.
This helps the patient to be cured easily and the acceptance of the drug would be easy and the known therapeutic
uses of the pharmaceutical products manufactured. Depending upon the aim, steps followed, the stability testing
procedures have been categorized into four types and they are
1. Real-time stability testing
2. Accelerated stability testing
3. Retained sample stability testing
4. Cyclic temperature stress testing.
Influence of Stability

6. Packaging plays a role in the overall perceived and actual stability of the dosage form is well established.
Packaging plays an important role in quality maintenance, and the resistance of packaging materials to moisture
and light can significantly affect the stability of drugs and their dosage forms. It is crucial that stability testing of
dosage forms in their final packaging be performed.
→Chemical and physical degradation of drug substances may change their PHARMACOLOGICAL effects,
resulting in altered efficacy therapeutic as well as toxicological consequences.
→Because pharmaceuticals are used therapeutically based on their efficacy and safety, and being stable
→For maintenance of quality until the time of usage or until their expiration date stability is important.
→The quality should be maintained under the various conditions that pharmaceuticals encounter, during
production, storage in warehouses, transportation, and storage in hospital and community pharmacies, as well as
in the home.

→Product instability of active drug may lead to under medication due to the lowering of the drug in dosage
form.
→During the decomposition of the drug or product it may lead to toxic products.
→ during the marketing from one place to another during the transportation the drug has the compatibility to
change its physical properties.
→Instability may be due to changing in physical appearance through the principles of kinetics are used in
predicting the stability of drug there different between kinetics and stability study.
Packaging lines
A packaging line is a production line on which finished products are packaged to protect them during
shipment and handling before use. Space is often a challenge in packaging lines, and therefore most marking
systems fit over or next to the primary line, rather than requiring to be inserted into the line itself.


The packaging material also provides a convenient surface to carry imprinted markings and codes that identify
the product and enable regulators and purchasers to track its progress through shipping to the retailer or
customer. In addition to packaging systems such as fillers, cartoners, case packers and palletizers, most
packaging lines also incorporate coding and marking devices to apply the essential codes that meet regulatory
requirements and enable accurate shipping traceability.
Influence of Packaging lines

7. Space is often a challenge in packaging lines, and therefor most marking systems fit over or next to the primary
line, rather than requiring to be inserted into the line itself. The marking systems are able to function effectively
from these positions and add to line productivity by keeping the line compact and efficient.
The inkjet and laser coding machines that apply the needed codes also collect valuable production data
summarizing the number and type products and packages being coded. Some coding systems also incorporate
vision systems that capture and store visual images of the packages being coded, to ensure their readability.
Speed and efficient operation and low maintenance are essential for these marking systems. Any slowdown due
to them will affect the productivity of the entire production/packaging operation. This why manufacturers of
coding and marking machines such as Videojet design them to apply codes quickly and efficiently, in addition to
producing codes that are permanent and readable.
Packaging lines use a wide range of packaging materials to package an extensive variety of products, from soft
to hard, large to small, solid to flexible. To successfully mark these packaging materials, manufacturers have
developed a broad selection of coding and marking machines, from laser printers and engravers to continuous
inkjet and thermal inkjet printers. This enables companies to select marking systems that work most effectively
with their unique packaging.

Packaging area
The area in which all processes related to packaging take place is called packaging Area.
• Packaging must take place in a separate area that is why a separate room is allotted for packaging.
• The area must be clean and should be well managed.
• All required machinery should be present in the packaging area.
• The area should be cleaned after specific interval of time.
• Blowers must be present in the area to stop dust particles to enter in the room.
Well trained personnel’s should be present in packaging Area.

Influence of Packaging area

8. • It protects and maintain the quality of drug
• Protects against physical and biological damage
• It carries correct information and the identification code of the product.
• Protects against any damage caused by external influences that can alter the property of the product.
Role of packaging in the pharmaceutical industry:
→ Handling and containment of product
→Protection against light, moisture, biological and mechanical damage and counterfeiting.
Material Characteristics:
→It must maintain the physical quality of all dosage and protect against all damage and breakage.
→It maintains the identity of product
→It maintains the characteristics properties of the product.
→It protects the product from deteriorating chemical, biological and physical entities.
Criteria for selection of packaging material:
• Moisture barrier requirement
• Light barrier requirement
• Gas barrier requirement
• Chemical requirement


Packaging Equipment

9. Flat Class Labeling Machine
To achieve the plane on the work piece, the arc of the label and foil, such as boxes, books, plastic shell, etc., are
rolling and smoking stickers
Round Bottle Labeling Machine
To achieve in cylindrical, conical circumferential surface of the product label or film, such as glass bottles,
plastic bottles
Strip Packing Machines
Features
It is a high-quality sealing machine that with attaining high speed.
Features like temperature controller, high pressure for sealing roller help this machine to attain high-quality
sealing.
Features like easily adjustable film feeding system, adjustable conveyor table makes this machine highly work
efficiently.
Heat resistant material like plated Teflon is used in it that results in excellent sealing with no issues of the films
melting.
The automatic wastage film collecting unit makes this machine most suitable for the job where minimum manual
intervention is the motto.
Cutter comes with the protective function to avoid any damage to the products.
The machine comes with the safety glass cover to protect an operator from the broken pieces and material flown
in the air.
Equipments that are used for packaging are called packaging equipments.

10. Applications
The machine is widely used for a variety of products like capsules, tablets, etc.
It is best to opt for heat sealable-coated films such as aluminum foil poly, paper poly, Glassine poly and
Cellphone poly, etc.
It is most suitable for a huge quality of packaging.
It is widely adopted in the production line for automatic production by large industries.
Examples of strip packaging machines are as follows - High-Speed Tablet Strip Packing Machine,
Automatic/Soft Double Al Strip Packing Machine, Rotary Type Tablet Strip Packing Machine, Automatic
Alu./Alu. packing machine and foil strip packing machine.

Blister Packaging Machines
Features
It uses blister materials such as polyvinyl chloride, polystyrene, and polypropylene for packaging.
Features like vibration feeder and crisp remover effectively eliminate the powder and crisps inside medicine.
The machine is capable of achieving multiple functions like Auto counting, waster-side cutting, horizontal
perforation, printing batch number and auto punch etc functions automatically in one process.
The diameter of heat pressing cam can be altered from 110 to 140 mm.

11. Applications
It widely opts for packaging of all kinds of liquid and solid in large and medium Pharmaceutical production
units, hospital preparation laboratory, food production and packaging units, Electronic and hardware industry,
etc.
Examples of blister packaging machines are as follows - Automatic Strip Blister Packaging Machine, PVC
Blister Packaging of Tablets, and Self-checking Molding Aluminum Blister Packaging Machine
Aluminum Foil Packaging Machine
Features
It is made up of molds like forming, heat seal, punch that can be adjusted keenly on the guide track.
It is best to opt for different size plates.
The machine is easy to adjust.
It has good adaptability and high accuracy.

12. Applications
It is best to opt for packing all kinds of liquid, solid product, paste through change the feeder.
It is best to opt for packing of hot sensitivity medicines.
Accucounter Tablet Packing Machine
Features
Features like high-performance counter make this machine capable of the precise cunning of capsules, pills,
tablets and identical products.
Its lustrous design and conventional controls make it a good looking machine.
It comes with dual nozzles made up of stainless steel for continuous filling and counting
It supports variable counting speed.
It has a dust accumulating device that protects the accuracy of the machine.

13. Applications
It is widely used for packaging tablets, caplets, capsules, transparent gel capsules, and much more.
Automatic Pouch Packing Machine
Features
This is a fully-automatic packing machine that first forms standup pouch, then fills it with a product and at the
end seal it.
The machine offers higher seal strength, less leakage and better pouch appearance.

14. Applications
It is widely used for food, cosmetics, chemicals, beverage and pharmaceuticals packaging.
The machine is suitable for various types of products, such as powder, small granule, liquid, viscous liquid,
paste, tablet, candy, solid, stick, large solid and irregular products.
Other types include:
• Accumulating and collating machines
• Blister packs, skin packs and vacuum packaging machines
• Bottle caps equipment, over-capping, lidding, closing, seaming and sealing machines
• Box, case, tray, and carrier forming, packing, unpacking, closing, and sealing machines
• Cartooning machines
• Cleaning, sterilizing, cooling and drying machines
• Coding, printing, marking, stamping, and imprinting machines
• Converting machines
• Conveyor belts, accumulating and related machines
• Feeding, orienting, placing and related machines
• Filling machines: handling dry, powdered, solid, liquid, gas, or viscous products
• Inspecting: visual, sound, metal detecting, etc.
• Label dispensers, printers, and applicators
• Orienting, unscrambling machines
• Package filling and closing machines
• Palletizing, depalletizing, unit load assembly
• Product identification: labeling, marking, etc.
• Sealing machines: heat sealer, tape, or glue units
• Security seals, tamper-evident bands, etc equipment
• Slitting machines, perforating, etc
• Strapping machines, banding machines, etc.
• Weighing machines: check weigher, multihead weigher
• Wrapping machines: flowwrapping, stretch wrapping, shrink wrap
• Form, fill and seal machines, bags, pouches
• Other specialty machinery: slitters, laser cutters, parts attachment, etc.