A seminar onRecent advances in

Pharmaceutical Packaging Technology

Presented by: Sonali R. PhadkeM.Pharm IV (QAT)

Guided by:Dr. Ritesh P. Bhole

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contentSr.no.

Title Slide number

1. Introduction 3-6

2. Need for advancements in

packaging

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3. Advances in packaging system

9-27

4. Role of quality assurance in packaging

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5. Conclusion 29

6. References 30-322

Introduction

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 fabrication of packages. A package consists of the container, closure, carton and box components.

Designing of package starts with the identification of all the requirements such as structural design, quality assurance, marketing, logistics, shelf life, legal, graphic design, end-use, regulatory and environmental etc. [1]

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While selection of package for pharmaceuticals following criteria should be considered.

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Criteria for packaging material selection

PACKAGE RAW MATERIAL APPROPRIATE FOR DOSAGE FORMRELATIVE BARRIERS, INERTNESS AND PROPERTIES OF PACKAGING MATERIALMETHODOLOGY AND EXPERIMENTAL SCHEME TO CHECK EFFECT ON SHELF LIFE

TESTS AND PROCEDURES TO ENSURE REPRODUCABILITY OF PRODUCT QUALITYPACKAGE INTEGRITY IN CHEMICAL, MECHANICAL AND CLIMATIC HAZARDS

Packaging systems are divided as follows:

Primary packaging system

e.g. bottles, vials

Secondary packaging system

e.g. papers, corrugated boxes

Tertiary packaging system

e.g. pallets, slip sheets

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Advantages of

packaging

Minimum side effects

Good stability

purity

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Need for advancements in packaging: In India, Pharma packaging today absorb a major

portion of the overall market. Previously, the requirements of Pharma packaging focused exclusively on preserving the quality of enclosed medicine.

Now, they are complete to cover such criteria: Preventing the tampering and counterfeiting of product, assuring the accuracy of product dispensing, promoting the patient compliance with respect to product dosage schedules.

Packaging of oral medicines generally conforms to requirements for uncomplicated dispensing, child resistant but senior-friendly, but packs must also be exclusive, purposeful and often hermetically sealed.

Advancement in the packaging machines itself has seen the incorporation of precise filling mechanisms, as the wrong dosage of a medicine could be life threatening.

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The smart approach to pharma packaging The Pharmaceutical industry is the perfect place for the

packaging industry to show off some of its advanced technology.

To improve the patient adherence to drug regimens - Compliance Packaging As the packaging industry continues to develop

increasingly sophisticated concepts, big Pharma is starting to embrace innovations in this field to improve patient adherence to drug regimens.

It's no exaggeration to say improvements in this area of pharmaceutical packaging have the potential to improve treatment outcomes and even save lives.

WHO suggest - in developed countries, only around 50% of patients with chronic diseases take their medication as prescribed. These levels are lowered in developing countries.

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Advances in packaging system Blow-Fill-Seal technology Blow- fill- seal technology was initially used for filling

many categories of liquids, such as non-sterile devices, foods and cosmetics. Recently, Blow- fill- seal technology is used to produce aseptically sterile pharmaceuticals such as respiratory solutions, ophthalmic, and wound care products.

Blow- fill- seal is an advanced aseptic processing technique within which plastic containers are formed by means of molded extruded polymer granules that are filled and sealed in one continuous process.

Advances in pharmaceutical packaging Tamper Evident Pharmaceutical Packaging[5]

Tamper evident pharmaceutical packaging can be defined as Packaging having an indicator or barrier to entry which, if breached or missing, can reasonably be expected to provide visible or audible evidence to consumers that tampering has occurred.

Tamper-evident packaging involves immediate-container/carton systems or any combination.

Various advanced technologies of making a Tamper-Evident Package

1. Induction cup sealing technology2. Induction wads3. Heat shrink bands or wrappers

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Advances in pharmaceutical packaging Induction cup sealing technology Induction Cup sealing technology is used to

create airtight and hermetic seals on the neck of the container.

The Induction Sealing process can be very easily incorporated on any existing filling lines from manual filling to the fully automated filling and capping lines.

Separate operation of sealing foil and lid assembly are no longer required.

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Advances in pharmaceutical packaging Induction wads The current is supplied to seal, due to flow of

current temperature increases and seal get adhere to a top of a container. After the seal is broken, the board or foam packing is retained by the cap.

It consists of four layers they are as followsa. Cardboard or Foam Packingb. Wax Layerc. Aluminum Foild. Sealing Film

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Advances in pharmaceutical packaging Heat shrink bands or wrappers Polymers like PVC has characteristics of heat-

shrinking which can be used to prepare heat shrink wrappers.

The polymer is manufactured as an extruded, oriented tube in a diameter slightly larger than the cap and neck ring of the bottle to be sealed.

Bands or wrappers with a distinctive design (e.g., a pattern, name, registered trade mark, logo, or picture) are shrunk by heat to seal the union of the cap and container.

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Advances in pharmaceutical packaging Bubble pack The bubble pack can be made in several

ways but is usually formed by sandwiching the product between a thermoformable, extensible, or heat-shrinkable plastic film and a rigid backing material.

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Advances in pharmaceutical packaging Novel Laser Coding Technology for

Pharmaceutical Glass Containers Glass syringes can now be individually coded / safe

process free of micro-cracks / Reliable Track & Trace. A completely new laser-coding system enables glass

containers for parenteral use to be clearly coded at the glass syringe manufacturer and tracked from production to end customer.

This innovation can help pharmaceutical companies to develop a reliable Track & Trace system and further reduce the risk of mix-up of syringes and batches.

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Advances in pharmaceutical packaging (Encouraging compliance through packaging)

Cypak's advanced medication monitoring and report card systems

This advanced packaging technology can enable patients to communicate with healthcare professionals through printed technology as well as connecting to the internet.

This record the time and date that a pill was taken based on when it is removed from its blister pack and allowing the patients to log their feedback on side-effects and treatment efficacy and upload it.

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Advances in pharmaceutical packaging(Encouraging compliance through packaging)

Stora Enso – Pharma DDSi Wireless This technology is based on conductive ink on a carton

board-based blister inlay, which is connected to a cellular module embedded in the package.

The removal of pills is tracked and the information can be sent to an electronic database automatically via GSM or GPRS cellular networks.

A Doctor can simply use the packaging data to track a patient's medication intake.

The system can also issue phone calls and text messages to the patient, healthcare professionals and even relatives.

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Advances in pharmaceutical packaging(Encouraging compliance through packaging)

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Pfizer’s - Four panel Toviaz wallet The four panel Toviaz wallet design provides a

comprehensive approach to initializing overactive bladder therapy, utilizing AmerisourceBergen Packaging Group IntuiDoseTM

A compliance prompting package design integrated with extensive The four panel folder format incorporates a patient guidebook complete with symptoms explanations, recommendations for managing Over Active Bladder, how to properly take medication, and ways to enroll in interactive programs. The package includes a daily tracker, functioning as a guide and diary to track goals and health improvement.

Burgopak's sliding CR blister pack UK packaging producer Burgopak's sliding CR blister

pack can only be opened by applying pressure at two separate points on the packaging. The blister pack and information leaflets are integrated with the outer box, which ensures the product is never separated from its packaging.

Burgopak Healthcare & Technology - won the award for the ‘Most Innovative Child Resistant Packaging Design’.

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Advances in pharmaceutical packaging(Encouraging compliance through packaging)

Advances in pharmaceutical packaging(Eco-Friendly Pharma Packaging ) Ecoslide –RX sustainable compliance packaging In August 2011, Keystone Folding Box Company and

Legacy Pharmaceutical Packaging launched their Ecoslide -RX sustainable compliance packaging.

The pack is made from 100% recycled material , using unbleached paperboard and a clay-coated surface designed to house blister packaging with minimum of unsustainable film and foil.

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Advances in pharmaceutical packaging(Eco-Friendly Pharma Packaging)

Syreen prefilled syringe design Syreen syringes replace glass with cyclic olefin

polymer (COP) The ability of packed syringes to clip into place

also eliminates the need for packing materials like styrofoam and cardboard.

Packaging weight reduction-30% and volume-50 %, compared to standard packaging.

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Advances in pharmaceutical packaging(Packaging against counterfeiting)

Counterfeiting means producing products and packaging similar to the originals and selling the fake as authentic products.

The current numbers of anti-counterfeiting solutions are many and new options are introduced in the market with some variations. An attempt is made to explain the technologies for easy understanding on product packaging.

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Advances in pharmaceutical packaging(Packaging against counterfeiting)1. Overt (visible) features Overt features are intended to enable end users to

verify the authenticity of a pack. Such features will normally be prominently visible, and difficult or expensive to reproduce. They also require utmost security in supply, handling and disposal procedures to avoid unauthorized diversion.

They are designed to be applied in such a way that they cannot be reused or removed without being defaced.

The list of overt features are follows: Holograms: Optically Variable Devices (OVD): Color Shifting Security Inks and Films Security Graphics Sequential Product Numbering On-Product Marking

Advances in pharmaceutical packaging(Packaging against counterfeiting)

2. Covert (Hidden) Features The purpose of a covert feature is to enable the

brand owner to identify counterfeited product. The general public will not be aware of its presence

nor have the means to verify it. If compromised or publicized, more covert features will lose some security value. The list of Covert features includes:

Invisible Printing Embedded Image Digital Watermarks Hidden marks and printing Laser coding Substrates Anti-copy and Anti-scan design

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Advances in pharmaceutical packaging(Packaging against counterfeiting)3. RFID (Radio Frequency Identification) Radio frequency identification (RFID) is hardly a new

concept. For some, RFID is already a mainstream technology-it is used every day to pay tolls, secure building access, catch shop lifters etc.

It allows the identification of objects through a wireless communications in a fixed frequency band.

The tag is an integrated circuit containing a unique tracking identifier, called an electronic product code (EPC), which is transmitted via E.M. waves in the radio spectrum.

The reader captures the transmitted signal and provides the network connectivity between tag data and the system. software.

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Advances in pharmaceutical packaging(Packaging against counterfeiting) However, other anti-counterfeiting solutions are: Security labelsi. Paper labels with security cutsii. Destructible labelsiii. Void labels and tapesiv. Holographic labelv. Security threads Hologramsi. Image choicesii. Media or the form of deliveryiii. Optically variable devicesiv. Sequential product numbering 26

Advances in pharmaceutical packaging(Packaging against counterfeiting)

v. Invisible printingvi. Embedded imagevii. Digital watermarks Forensic markersi. Chemical taggantsii. Biological taggantsiii. DNA taggantsiv. Micro-taggants Mass encoding/trace and track technologiesi. Barcodesii. Auto identification systemsiii. Digital mass serialization 27

Role of QA in packaging The purchase, handling and control of primary and

printed packaging materials should be as for starting materials.

Cut labels and other loose printed materials should be stored and transported in separate closed containers so as to avoid mix-ups.

All products and packaging materials to be used should be checked on delivery to the packaging department for quantity, identity and conformity with the packaging instructions

When the program for packaging operations is being set up, particular attention should be given to minimizing the risk of cross-contamination, mix-ups or substitutions.

Printed and embossed information on packaging materials should be distinct and resistant to fading or erasing.

5 Upon completion of a packaging operation, any unused batch-coded packaging materials should be destroyed and the destruction recorded.

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conclusion Packaging should provide protection,

identification, information, convenience and compliance for a product during storage, carriage, display and until such time the product is consumed.

Pharmaceutical packaging should look into concerned issues like child safety, patient compliance, patient traceability, tampering and diversion of pharmaceutical products.

Considerable steps have to be taken to ensure packaging traceability (e.g. RFID, Barcodes etc.)

Advanced integrated robotic systems are becoming more and more common in packaging lines for a wide variety of applications and at the same time it lowers costs, reduces risks, and shortens times.

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References

1. Jain U. K., Goupale D. C., Nayak S. Pharmaceutical Packaging Technology. PharmaMedPress, First reprint; 2009: 1-16.

2. Ghanshyam Balkrishna Jadhav, Amar Gangadhar Zalte,Ravindranath Bhanudas Saudagar. ADVANCES IN PHARMACEUTICAL PACKAGING.WJPPS, Vol.3, Issue 5, 2014:194-204.

3. S.Wasim Raja et.al. INNOVATIONS IN PHARMACEUTICAL PACKAGING – AN UPDATE. Int. Journal of Advanced Biomedical & Pharmaceutical Research.2012, 1(1): 29-39.

4. WHO Guidelines.(http://www.who.int/medicines/areas/quality_safety/quality_assurance/QualityAssurancePharmVol2.pdf)

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5. Kumbhar M. S., Choudhary N.H., Dighe D.A., Singh M.C. Tamper Evident Pharmaceutical Packaging – Needs And Advances. International Journal of Pharmaceutical Sciences Review and Research; 2012, 13(2): 141-152.

6. AmerisourceBergen: AmerisourceBergen Debuts New CIAB Configuration. PMPN, 2009 17(3). Available from: http://www.pmpnews.com/article/amerisource bergen-debuts-new-ciab-configuration

7. http://burgopakhealthcare.com/2012/04/another-award-win-for-the-burgopak-child-resistant-slider-pack/

8. Sunil Kumar. Pharmaceutical Packaging Technology - A Review. International Journal of Research in Pharmaceutical and Biomedical Sciences; 2013, 4(4): 1413.

9. Mehta K. C., D. Akhilesh., B. Shyam Kumar. Recent Trends in Pharmaceutical Packaging: A Review. International Journal of Pharmaceutical and Chemical Sciences;2012, 1(3): 936.

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10.Khunt B. P., Dharajia H. V., Desai T. R., Shah K.V.. Innovation in Packaging: A Review.International Research Journal of Pharmaceutical and Applied Sciences; 2012, 2(2): 65-78.

11.James Swarbick. Encylopedia of Pharmaceutical Technology. Informa Healthcare. Third Edition. Volume-1; 2007: 378- 379.

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Thank you

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