MOST IMPORTANT SLI

1. Abdul Muheem
M.Pharma(Pharmaceutics)
Faculty of Pharmacy
Jamia Hamdard
muheem.abdul985@gmail.com

2. Introduction –
 Package engineering and Packaging Science, is a broad topic ranging
from design conceptualization to product placement.
 Package design and development are often thought of as an integral
part of the new product development process.
 Quality control of a packaging component starts at the design
stage.
 Packaging is a critical tool in the pharmaceutical industry for product
delivery and regulatory compliance, many pharmaceutical
companies will do all their packaging within a contamination free
environment or Cleanroom.
 The terms active packaging, intelligent packaging, and smart
packaging refer to packaging systems used
with foods, pharmaceuticals, and several other types of products.

3. What is packaging ?
 Packaging is the science, art, and technology of enclosing or
protecting products for distribution, storage, sale, and use.
 Packaging also refers to the process of design, evaluation, and
production of packages.
 It is the process by which pharmaceuticals are suitably placed
so that they retain their therapeutic activity from time to time
of their packaging till they are consumed.

4. Objective of packaging
 Presentation
 Identification ,information
 protection
 Convienence,complaince
 Containment during storage
preserves of integrity of
products

5. Types of packaging
• Direct contact with
primary product
• Maintain product quality
• Contains product and
secondary primary pack
• Presentation, protection
• Transport shipping
tertiary ,warehouse storage, bulk
handling

6. Tertiary
packaging Product
Primary
packaging
Secondary
packaging

7. Packaging design
 Proprietary name
 Dose
 Approved name of API
 Uses
 Usage instruction
Prescription drugs-straight
forward design
OTC drugs-distinctive design

8. Why are required packaging designs-
 Product quality must be maintained.
 Customers must be able to easily access and use the product without
harming themselves or contaminating the product .
 The component manufactures must be capable of making the components
to the required specifications.
 The pharmaceuticals equipment must be capable of handling the
components & maintaining product quality & production efficiency.
 All aspects of a pack development that may give rise to quality problems
must be identified & minimized by good design.
 One suitably experienced person should be assigned the responsibility of
designing a pack .
 This packaging design coordinator must be fully aware of the involvement
required by marketing, quality assurance & production.

9. Packaging designs
 Component shape and dimensions
 Marketing involvement
 Packaging validation trails
 Material of construction
 Component/product validation
1. Sterile product/pack validation
2. Nonsterile product/pack validation
 Product considerations
 Customer usability
 Print requirements
 Regulatory requirements

10. Component shape and dimensions
 There may be product-specific design requirements in some
instances,but there are many components that can be
standardized, such as ampules, vials, cartons ,labels and leaflets.
 There will be variety of sizes of components, but again the same
shape could be used with different dimensions.
 There are several adv. to standardizing components-
1. Minimizing the packaging validation trails.
2. Enabling large quantities of unprinted components to be
ordered at a time.
3. Reducing the numbers of packaging machine changeover for
different types of pack.

11. 4. Shortening the lead time.
5. Allowing more utilization of the packaging equipment.
6. Fewer component drawing will be required to reducing the
administrative work in preparing, updating &distribution drawing.
7.Reducing inventory.
 Nonstandard production components will probably be more
expensive to buy.

12. Marketing involvement-
 Consultation with marketing staff should take place when a
basic, practical design has been developed.
 They may help sell OTC pharmaceutical products, although the
prime consideration must be the product safety and security.
 Once a final product has been agreed ,the emphasis should be on
minimizing the variations of packs for different markets.
 One possible method of minimizing variations is to provide a
product prospectus to the sales staff.

13. Packaging validation trials-
 Prepare a validation protocol detailing all the tests required and
standards to be maintained.
 An eq-foiling and packaging of the tablets(heat sealing operation
by methylene blue),determined the methods and rate of
monitoring for each operation to ensure that the quality is
satisfactory.
 Extremely hygroscopic tablets may pick up the moisture during
foiling ,therefore foiling may require humidity controlled
conditions.
 the replacement of equipment on a packaging line with updated
or modified equipment will require the revalidation.

14. Material of construction
 The main reason for the tight control over container
manufacture is to ensure that changes are not made that can
cause product degradation, particularly if the product is liquid.
 Authorities such as the FDA and overseas licensing authorities
will require such details before a manufacturing license is issued.
 A good example to consider is a plastic bottle containing a
product.

15. Component/product validation-
 Product stability studies will identify the effect of the moisture
,light and compatibility studies .
 The following two examples show the approach required for
1. sterile product
2. nonsterile product
Sterile product/pack validation
 To start with, the components and products to be used must be
full tested and passed the relevant specifications.
 Each components must be validated through washing and
sterilization stages. Then the developing work required relating
to the pack would be as follows-
a-product and pack compatibilty
b-seal integrity

16. Non sterile product-
 Non sterile product may still require extensive trials to ensure it’s
suitability for the market.
 If moisture –sensitive tablet packaged in a polypropylene screw-
cap bottle, the following validation work will be required.
a-water vapor permeability
Bottle wall permeation bottle and cap permeation
b-light transmission
c-product/pack stabilty

17. Product considerations
 The product must be carefully considered during packaging
design.
 The packaging operation can be influenced if the tablet is the
wrong shape for filling /packaging equipment concerned.in
which table shape and pack are closely related.
 The adv. & disadv. Of both marketing & packaging must be
carefully considered before a final decision is made.

18. Customer usability
 Customers must be able to open the pack & remove the contents
without harming themselves or contaminating product.
 If a product contained glass ampule must be capable of being
opening without the ampule breaking & without the customer
cutting the finger.

19. Print requirements
 The artwork must be checked by a competent person, who is
fully aware the labeling, regulations, product details ,& the
implications of any mistake missed.
 The print color should be chosen carefully.
 When dispenses the product, a label is usually placed on the
container or carton ,detailing the dosage form & any other
special instructions.
 Allowing a blank space on the pack for the pharmacist’s label is
worth considering when designing the artwork.

20. Regulatory requirements-
 Prior the sale of the product, the regulatory requirements of the
country in which the product is to be sold must be met.
 The whole issue of regulatory requirements can be difficult to
understanding in deciding what is required for new products,
how it is to be presented & what changes to processes require
notification to the authorities .
The main requirements are as follows-
1. New drug application(NDA)
This must be submitted & prior to the sales of the product on the
market.
2.Supplemental new drug application type 1-
This must be submitted when major process changes are required.

21. The supplemental NDA must be approved before the changes takes
place.
3. Supplemental new drug application type 2-
This is a change important enough to require a supplement but
does not require FDA approval prior to implementation.
4.Annual NDA reports-
A report must be submitted that details the changes that have
taken place over the year that do not require a supplemental
applications.
5.Drug master file-
 It is not legally required that a pharmaceutical company submit a
DMF.
 DMF is a submission to the FDA that may provide detailed
information about facilities, process or articles used in the

22. packaging ,manufacturing, processing and storage of one or more
pharmaceutical products for human use.

23. Component specifications
The main specifications requirements are the components
drawing, artwork (printed components only),& the quality tests &
standards.
A.Component drawing
The best method for preparing a component drawing is to use a
computer system. This will enable rapid preparation & updating of
drawing.
Several rules should be observed-
1-the following details should be stated-
a) Explicit title.
b) Specific reference code & version number.
c) Date from which drawing is to become
impactive.

24. d)Component specification reference number
e)Material of construction
f)Terminology used, that is the description of each point of
measurement.
g)Dimensional limits & units.
2-A circulation list for each copy of drawing should be available .
3-Enlarge areas of the component drawing to clarify dimensional
details when necessary.
4-index each dimension with a number on the drawing to prevent
mistaking them for dimensional data .
5-complete drawing must be checked to ensure that all the details
are correct.
These rules are completely understood, hence minimizing the
possibility of errors.

25. B- Artwork
 There must be no errors on the completed artwork.
 The artwork is the prime reference document for the pharmaceutical
company quality assurance staff & the supplier.
 Several rules should be adhered to-
1. A specific reference code & version number should be assigned on the
artwork. Whenever artwork is modified ,the version number must be
changed.
2. A circulation list should be available for each copy of the artwork.
3. The date at which the artwork is to become effective is required.
4. Suppliers must not be allowed to prepare their own artwork from the
master supplied by pharmaceutical company ;this can lead to artwork
errors. The artwork should be computer generated.

26. 5. The artwork should be color separated.
6.Stick –on lettering on the artwork should be avoided .
7.The exact position of the artwork text ,color bands & figures
should be shown in relation to the component.
8.Print size & type to be used need careful consideration.
9.Type & color of ink to be used must be stated.
10. any changes are made to the artwork that render the old version
unsuitable for use.

27. C.Quality control testing & standards
 If a serious compliant or a product recall occurs ,the batch
system will help determine the problem source & identify the
suspect material on the market.
 There are two classes of components-
1-Primary-in contact with product eq-ampules,vials,plastic bottle,
polymer-coated foils
2-Secondary-eq-cartons, labels, leaflets
 Basic testing are same for both types of components, but
additional testing for primary testing such as component
compatibility & chemical testing.
 Both must be tested during manufacture (in process control) to
ensure the best quality of product.

28. The critical parameters requiring control need defining-
1. Setting the standards- several distinct areas :
a) Appearance
Critical major minor
(unacceptable (acceptable at (acceptable at
At any levels) low levels) higher levels)

29. b. Dimensions
1.Critical 2.Noncritical
Requiring close control necessary to maintain
to ensure that the component component shape but not
functions correctly requiring close control.

30. 3. Measuring components
 It is not possible to accurately measure components without
trained staff & variety of measuring equipment such as
micrometers,callipers & an optical projector.
 Prior to purchasing equipment ,make sure that equipment is
reliable ,easily calibrated ,& is of known precision & accuracy
throughout it’s measuring range.

31. 4. Precision and accuracy
 Once a measuring technique is clearly defined.
 Next aspect to consider to consider is the equipment precision &
accuracy .
 First ,a set recently calibrated gauging blocks are required (from
reputed source),together with a certificate of calibration.

32. 5. Measurement standards-
 Type of measuring equipment, & calibrated ,it is necessary to
decide the number of components to be measured & the
standards to be applied.
Molded components non molded components
PVC components glass ampules, tubular,
vials ,collapsible aluminum
or laminated tubes

33. 6.Computerization of measuring equipment
There are several advantage to computerization-
 Prevention of operator transcription errors.
 Rapid recording of all results
 Audible indication when results are outside limits(if required)
 Instant computer statistical calculation & printout of results
 Printout in a standard work book format
 Inclusion of measuring instructions.

34. c. compatibility & customer usability
 Checking that each component forming a pack fits together &
functions correctly.
 Good example is eye dropper. The nozzle must have a good
interference fit into bottle & allow one-drop-at-a-time delivery
through the hole in the nozzle when inverted ,but must not leak
from the fitted position.

35. d. Chemical testing
 The majority of chemical testing is required on primary
components.
 Product degradation or contamination may occur if wrong
construction material or unacceptable contaminants are present.
 Type of testing required depends on the type of component
used-(1)Glass vials & Ampules-the USPXXII requirements for
glass container are chemical resistance and light transmission.
(2)Plastic primary components-requiring both biological &
physiochemical tests, because plastic components contain other
substances such as plasticizer ,stabilizers ,antioxidants ,pigments
,lubricants & possibly residues from polymerization.

36. D. Component specification layout
 There is a tremendous amount of information to include in the
specifications.
 Rather than having to reissue the whole specification when any
of the above changes are necessary.
 It’s suggested that component specification be split into four
parts as follows-
1- General specification ,which states the appearance standards,
labeling requirements , packaging & transportation details,& lab
testing standards & techniques as well as any other items that are
not likely to change very often.
 Should have a reference number.

37. 2-The artwork should be a separate document, with a reference
number included on the artwork.
3-The drawing for a component should also be a separate
document ,with a drawing reference number.
4-The testing methods for both chemical & dimensional checks
will be general documents, relevant possibly to a whole class of
components eg-carton,vials,labels.
 The splitting of the specification into four separate units making
updating much easier.
 Standardization with a basic component design will make this
layout & system of issuing a specification all the more useful.

39. References-
 Annex 9,Guidelines on packaging for pharmaceutical Product, WHO
Technical Report Series, No. 902, 2002.
 Pharmaceutical Packaging Technology by Dixie A. Dean, Roy
Evans, Ian Hall.
 Quality Control of Packaging Materials in the Pharmaceutical Industry
By Kenneth Harburn Published October 26th 1990,Taylor & Francis.
H. Lockhart, F. Albert Edward J. Bauer W. A. Jenkins

41. Thanks for yours attention