Packaging Designs And Specifications

Abdul MuheemM.Pharma(Pharmaceutics)

Faculty of PharmacyJamia Hamdard

muheem.abdul985@gmail.com

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.

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.

Objective of packagingPresentationIdentification ,informationprotectionConvienence,complainceContainment during storage

preserves of integrity of products

Types of packaging

primary

secondary

tertiary

• Direct contact with product

• Maintain product quality

• Contains product and primary pack

• Presentation, protection

• Transport shipping ,warehouse storage, bulk handling

Product

Primary packagingSecondary

packaging

Tertiary packaging

Packaging designProprietary nameDose Approved name of APIUsesUsage instruction

Prescription drugs-straight forward designOTC drugs-distinctive design

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.

Packaging designs Component shape and dimensionsMarketing involvementPackaging validation trailsMaterial of constructionComponent/product validation1. Sterile product/pack validation2. Nonsterile product/pack validationProduct considerationsCustomer usabilityPrint requirementsRegulatory requirements

Component shape and dimensionsThere 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.

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.

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.

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.

Material of constructionThe 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.

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 productSterile product/pack validationTo 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

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

Product considerationsThe 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.

Customer usabilityCustomers 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.

Print requirementsThe 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.

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.

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

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

Component specificationsThe main specifications requirements are the components drawing, artwork (printed components only),& the quality tests & standards.

A.Component drawingThe 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.

d)Component specification reference numbere)Material of constructionf)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.

B- ArtworkThere 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.

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.

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 foils2-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.

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)

b. Dimensions

1.Critical 2.NoncriticalRequiring close control necessary to maintain to ensure that the component component shape but notfunctions correctly requiring close control.

3. Measuring componentsIt 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.

4. Precision and accuracyOnce 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.

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 componentsPVC components glass ampules, tubular, vials ,collapsible aluminum or laminated tubes

6.Computerization of measuring equipmentThere are several advantage to computerization-Prevention of operator transcription errors.Rapid recording of all resultsAudible indication when results are outside limits(if

required)Instant computer statistical calculation & printout of

resultsPrintout in a standard work book formatInclusion of measuring instructions.

c. compatibility & customer usabilityChecking 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.

d. Chemical testingThe 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.

D. Component specification layoutThere 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.

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.

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 

Thanks for yours attention