VALIDATION OF PACKAGING OPERATIONS

Presented By : Anchal Kesari M.Pharm. (QAT)

Guided By : Mr. Mukesh T. Mohite (Asstnt. Prof.)

Padm. Dr. D.Y. Patil College of Pharmacy, Akurdi

Pune-44.

2

CONTENTS:

Introduction Selection criteria for packaging

material Characteristics of packaging material Types of packaging Types of packaging materials Validation Protocol VMP Sampling and testing Q.A. aspects Blister Packaging Strip Packaging

3

INTRODUCTION :

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

Packaging Validation : to confirm that the resulting product from a specified packaging process consistently conforms to product attributes & requirements.

4

Selection

Criteria

Product Content

Need of Protectio

n

Product Applicati

on

Content Reactivit

y

5

CHARACTERISTICS OF PACKAGING MATERIALS:•Must meet tamper-resistance

requirements

•Must be FDA approved

•Must be non toxic

•Must not impart odor/taste to

the product

•Must not reactive with the

product

•They must protect the

preparation from environmental

conditions

6

TYPES OF PACKAGING:

1. Primary packaging is the material that first envelops the product and holds it. This usually is the smallest unit of distribution or use and is the package which is in direct contact with the contents.

Eg: Ampoules,Vials ,Containers ,Syringe ,Strip package, Blister packaging.

7

2. Secondary packaging is outside the primary packaging – perhaps used to group primary packages together.

Eg: Paper and boards, Cartons

8

3. Tertiary packaging is used for bulk handling , warehouse storage and transport shipping. The most common form is a palletized unit load that packs tightly into containers.

9

Apart from primary and secondary packaging, two types of special packaging are currently in use, as follows:

• Unit-dose packaging. This packaging guarantees safer

medication by reducing medication errors; it is also more practical for the patient.

• “Device” packaging. Packaging with the aid of an

administration device is user-friendly and also improves compliance. This type of packaging permits easier administration by means of devices

such as pre-filled syringes, droppers, transdermal delivery systems, pumps and aerosol sprays.

Such devices ensure that the medicinal

product is administered correctly and in the right amount.

10

TYPES OF PACKAGING MATERIALS:

I) Glass

II) Metals

III) Rubbers

IV) Plastics

V) Fibrous material

VI) Films, Foils and laminates

11

Packaging

Materials

ADVANTAGES DISADVANTAGES

GLASS • suitable for sterilization• relatively non- reactive • easily labeled

• relatively heavy• fragile so easily broken

METALS Impermeable to moisture, gases, odors, light, bacteria, and shatterproof

• Liable to corrosion • Less flexible.

RUBBERS Used to form closures • Risk of product absorbing on or in to a rubber.• Has certain degree of moisture & gas permeation

PLASTICS • Flexible • No risk of breakage• Light in weight

• Not chemically inert• May possess an electrostatic charge which will attract particles.

FIBROUS MATERIAL

Provides physical protection especially to items like metal collapsible tubes

FILM, FOILS and LAMINATE

• can extend the storage period of drugs. • suitable for packing moisture-sensitive drugs

12

VALIDATION PROTOCOL: Short description of the process with a

summary of the critical processing steps or critical parameters to be monitored during validation.

Additional testing intended to be carried out e.g. with proposed acceptance criteria

and analytical validation as appropriate.

Sampling plan — where, when, how and how many samples are taken.

Details for recording and evaluation of results.

13

VALIDATION MASTER PLAN (VMP):

The change control process used Validation Master Plan will include key elements of the validation program-

Company’s validation policy Organizational structure of validation

activities Summary of facilities, systems,

equipment and processes validated/to be validated. All critical equipment, systems, devices, software must be identified and listed.

Defines nature & extent of testing, test procedures

Documentation format (e.g. protocol and report)

Planning and scheduling Change control process

14

SAMPLING AND TESTING OF PACKAGING MATERIALS:

Sampling : To check the correctness of the label,

packaging material or container references. Detecting adulteration of the medicinal

product. The sampling procedure should be

described in a written protocol. Testing :

Visual inspection (cleanliness, defects)Tests to identify the material Dimensional tests Physical tests Chemical tests Microbiological tests

15

Q.A. ASPECTS OF PACKAGING:

To ensure that patients and consumers receive high-quality drugs.

The quality management system must take the following considerations into account if the required quality of packaging is to be obtained:— the requirements of the national authorities

and the relevant legislation— the product— the production process— the manufacturers’ internal policies (safety,

marketing, etc.).

Bad packaging which is the result of deficiencies in the quality assurance system for packaging can have serious consequences, and packaging defects can create problems that may result in drug recalls.

Eg: breakage, problems relating to printing or inks, or errors on labels and package inserts (patient information leaflets).

16

BLISTER PACKAGING:

Blister pack:

“Blister pack or bubble pack is a term for several types of pre-formed plastic Packaging used for small consumer goods, foods, and for pharmaceuticals”

Blistering:

“Blistering is the process of making Blisters or enclosing the tablets & capsules into preformed plastic packing”

17

I] BLISTER PACKING COMPONENT…

The four basic components of pharmaceutical blister packages are;• The forming film (Forming films account for approximately 80–85% of the blister package)

• The liding material (liding materials make up 15–20% of the total weight of the package)

• Heat seal coating

• The printing ink

18

II] BLISTER PACKAGING MACHINE…

Heating the plastic

Thermoforming it into blister cavities

Loading the blister with the product

Placing lidding material over the blister

Heat-sealing the package

I) Thermoform Blistering machine:Example : ALU-PVC machine

19

FIG 2: Thermoform Blistering Machine

20

II] Cold Forming Blistering machine:Example: ALU-ALU Machine

Operation sequence involves;

Installing the Aluminium Foil

Cold forming it into blister cavities via punch pins

Loading the blister with the product

Placing lidding material over the blister

Heat-sealing the package

21

1. Bottom foil uncoiler 6. Cover foil uncoiler11. Discharge conveyor

2. Cold forming station 7. Cooling & slitting 3. Feeding device 8. Draw Off 4. Empty checker 9. Punching 5. Sealing & Embossing 10. Waste foil coiler

22

III] Thermo-cold forming blistering machine:Eg: ALU-Tropical Machine Operation: The Operation sequence involves;Heating the plastic

Thermoforming it into blister cavities

Loading the blister with the product

Placing liding material over the blister

Heat-sealing the packageInstalling the aluminium

foil

Cold forming it into blister Pouch & seal it on thermoformed blister to give extra protectionCutting into individual

blisters

23

FIG 3:Thermo-cold forming Machine

24

STRIP PACKING:

It is commonly used for the packaging of tablets and capsules. A strip package is formed by feeding two webs of a heat sealable flexible film through a heated crimping roller .The product is dropped into the pocket formed before forming the final set of seals. A continuous strip of packets is formed which is cut to the desired number of packets in length.

The materials used for strip package are cellophane, polyester, polyethylene, polypropylene, polyvinylchloride.

25

SUMMARY:

Industry Constantly challenged to reduce costs New markets and new packs add

complexity to the operation An ever changing regulatory environment

demands compliance.

To ensure pack integrity, manage complexity, maximize efficiency and minimize costs; appropriately designed packs, running in validated packaging lines, are a business necessity rather than a regulatory requirement.

If validation is well planned and documented, then GMP compliance will naturally follow.

26

Visible costs e.g., waste, returned /

recalled goods

………………………………………… ……

Invisible/Hidden costs

e.g., wrong decisions, non-trained workers,

Non-standardized process,unsuitable packaging material etc.

Importance of Validation : Cost of Quality

27

Quality is designed and built into the

process/method/equipments/premises

Functionality, consistency and repeatability

is confirmed by Validation

28

REFERENCES

Pharmaceutical Process Validation, Third Edition, Ira R.Berry & Robert Nash, Marcel Decker Inc.

Pharmaceutical Validation Master Plan by Syed Imtiaz Haider, St. Lucie Press

www.ijpqa.com www.pharmaceuticalvalidation.blogspot.in

29