Complete Information and knowledge about the selection criteria for packaging material and different test used for them . All this material data is , Collected for seminar in QA SEM 2 , in the Subject of Pharmaceutical Manufacturing Technology . Which also explain the How Quality control for Filling an pharmaceutical equipment is done.

1. QUALITY CONTROL OF PACKAGING
MATERIAL AND FILLING EQUIPMENT
GUIDED BY :
Dr. Mithun Bandivadiker
Prof . AISSMS COP ,Pune
Presented by
Mr. Shankar D. Maind
M.Pharm (Quality Asssurance)
28/07/2023
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2. INDEX
1. Introduction
2. Characteristics of Packaging materials
3. Role of Packaging
4. Selection of the Packaging materials
5. ideal Requirements of Packaging Materials
6. Types of packaging material
7. Packaging Evaluation
8. Filling Equipments
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3.  Packaging is the process by which the pharmaceuticals are
suitably packed so that they should retain their therapeutic
effectiveness from the time of their packaging till they are
consumed.
 Packaging may be defined as the art and science which
involves preparing the articles for transport, storage, display
and use.
 Types of Pharmaceutical Packaging Materials:-
 Glass
 Metal
 Plastic
 Paper and board 3

4. ROLE OF PACKAGING
 Protection - Against light
 Against reactive gases
 Against moisture
 Against microbe
 Against physical damage
 Against pilferage and adulteration
 Presentation
 Identification
 Information
 Compatible
 Convenience 4

5. SELECTION OF PACKAGING MATERIAL
1. On the cilities available, for example, pressurized dispenserrequires special filling
equipment.
2. On the ultimate use of product. The product may be used by skilledperson in hospital or
may need to be suitable for use in the home by a patient.
3. On the physical form of the product. For example, solid, semi-solid, liquids or gaseous
dosage form.
4.On the route of administration. For example, oral , parenteral, external, etc.
5. On the stability of the material. For example, moisture, oxygen, carbon dioxide,
light, trace metals, temperature or pressure or fluctuation of these may have a
deleterious effect on theproduct.
6. On the contents. The product may react with the package such as the release of alkali
from the glass or the corrosion of the metals and in turn the product is affected.
7. On the cost of the product. Expensive products usuallyjustify
 expensive packaging
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6. TYPES OF PACKAGING MATERIAL
 1). Primary Packaging
 2) . Secondary packaging
 3). Tertiary Packaging
 4). Quarternary Packaging
 PACKAGING MATERIAL
 Glass
 Plastic
 Rubber
 Metal 6

7. 1). GLASS
 There are 4 Types of glass
 1). Borosilicate glass
 2). Treated Soda Lime Glass
 3). Soda Lime Glass
 4). NP Glass (Non –Parentral)
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8. QUALITY CONTROL OF GLASS
As per USP
, Mainly Three Tests are done:
1) Water Attack Test
2) Hydrolytic Resistance Test
3) Powder Glass Test
 Water Attack Test
The water attack test at 121C is performed on intact containers.
The containers are filled up to 90% of their overflow capacity Containers are autoclaved for 60 min.
Then content of container are cooled & from cooled content 100m1 of the solution.
Rinse 3 or more containers with high purity water Fill each container to 90% of its overflow capacity
Cap all the flasks, autoclave for 60 min
Empty the contents & cool the contents in 250ml conical flask to a volume of 100m1 Add five
drops of methyl red solution
Titrate with 0.02N Sulphur acid while warm Record the volume consumed Volume should not exceed
limits.
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9.  2). Hydrolytic Resistance test

TYPE 1 TYPE2
Wash containers with carbon dioxide
free water
 Fill the containers with CO2 free
water (90%
 Close with aluminum foil
 Autoclave at 1009-1209C for 20 min
 Maintain at 120°C for 1 hr.
 At lower temp for 40 min
 Remove containers & cool
 Titrate it within 1 hour
 Titrate with 0.01 M HCL (end point
colorless)
 Repeat with same volume of CO2
free water
Rinse container twice with water and
with 4%volume solution of HF
• Allow to stand for 10min
• * Empty the container
• * Rinse 5 times with water
• * Carry out test similar test 1
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10. 3). POWDER GLASS TEST (AS PER U. S. P.)
Transfer 10.0g of prepared specimen in 250ml conical flask
digested previously with high purity water in bath at 90°C
Add to conical flask containing 50ml of high purity water Cop all
the flask Autoclave (continue heating for 10min)Close vent
cock Adjust tap to121°C Hold the temp (121°C 1221°C for
30min)
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11. QUALITY CONTROL FOR PLASTIC
CONTROLLER
 1). Leak Test
 2). Water Permeability Test
 3). Collapsibility Test
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12. QUALITY CONTROL FOR RUBBER CLOSURES.
 1). Sterility
 2). Penetrability
 3). Fragmentation
 4). Self Sealibility
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13. QUALITY TESTS FOR METALS
 1. Description
 2). Dimension
 3. Diameter
 4). Cleanliness
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14. QUALITY OF FILLING EQUIPMENT
 Legal requirements regarding fill quantities of pre
packaged goods exist in practically every industrialized
country.
 But how do you comply as a small- or middle-sized food
manufacturer with only a few hundred or thousand
packages a day?
 The classic approach is to manually take samples, check
the weight and store the results.
 But for a more economical approach, the following
considerations may help in your decision-making
process:
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15.  Compliance
The control system should satisfy all legal requirements, especially the obligation
to record and prove compliance in EU countries, the USA and other countries.
 Easy operation
A modern control system should be designed to make the job of control
operators as easy as possible. If at all possible, the routine sampling inspection
should be performable without the need for additional function-switching to keep
incorrect operation to a minimum.
 Immediate feedback
The result of the sampling inspection including the statistics should be displayed
and/or printed out directly at the weighing station immediately following a
sampling procedure. The operators at weighing stations should know the result
of their actions instantly so that inadvertent errors can be detected and corrected
without undue delay.
 Harsh and wet industrial environment resistance
Consider common sanitation rules for production. Installations should be easy to
clean and resistant to common washing procedures.

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16.  Packaging and filling quality control
 The IND890SQC terminal is a stand-alone compact
solution that has been developed for manual random
sampling for net-content control.
 It helps to ensure correct packaging of high-quality
products in line with international and national net-
content legislation as well as global guidelines, such
as IFS or BRC standards.
 The SQC-890 application helps rule out illegal
underfilling, reduce overfilling costs and allows easy
data storage and documentation for audits.
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17.  Once the bag is filled and closed, it is passed to the bag
handling equipment for processing and quality checks
before being palletized.
 Powdered food and dairy products, for example, must
be checked for conformance with production parameters
.
 such as weight accuracy or contamination — before
they reach the finished product store.
 Containers that do not conform to weights and
measures regulations are rejected.
 An operator can then take remedial action. This is
usually limited to discarding or reprocessing of product.
 A more critical non-conformance is that of contamination
from foreign bodies.
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18.  In the event of a positive result, our integrated line control system will
automatically stop the powder filling process and immediately alert
the plant operator to take action.
 Standard solutions include
 large aperture metal detectors
 X-ray metal detectors
 automatic container rejection
 coding systems
 check-weighers
 bag reject units
 bag turners, kickers and flatteners
 Optional connectivity of the check-weighing and bag coding
equipment enable both local and remote monitoring, and data
analysis, using the customer's own SCADA system.
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19. 1). CHECK WEIGHER
SOLUTIONS
High performance weighing solutions for all industries
MID certified dynamic check weighing solutions for
compliance with weights & measures regulations and
quality control in industries such as meat, poultry &
seafood, pharmaceutical, cosmetic, ready meals and
baby food production.
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20. 2).Metal Detection - Safeline
 Detecting and rejecting metal contamination in food and
pharmaceutical applications
 Industrial metal detectors and metal detection systems
can safely detect and reject metal contamination from
production lines to help manufacturers achieve
compliance, minimize risk of product recalls and reduce
production downtime.
 Metal detection systems are available for a range of food,
non-food and pharmaceutical applications.
 Our portfolio includes tunnel and throat metal detectors,
and gravity fall, pipeline, pharmaceutical and
conveyorized metal detection systems.
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21.  3). X RAY INSPECTION SOLUTION
 4). TRACK TRACE SOLUTIONS
 5). VISION INSPECTION SOLUTIONS
 6). PRODX QUALITY AND FOOD SAFETY
 PROCESS MANAGEMENT SERVICE.
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22. REFERENCE
 https://www.mt.com/sg/en/home/supportive_co
ntent/news/po/ind/quality-control-6671.html
 Selection OF PACKAGING MATERIAL ,
Slideshare.net Hemant rathod
 Evaluation of packaging material , Scribd .com ,
Tushar Naik .
 Pharmaceutical packaging technology ,H Hall
D A Dean , Taylor & Francis
 https://www.gea.com/en/products/filling-
packaging/quality-control-equipment/index.jsp
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