Presented By Jitendra yadav MPharm 2nd sem.

 Pharmaceutical packaging is the means of providing protection,

presentation, identification and information, containment, and convenience to encourage compliance with container and closures. There are two types of packaging. 1. Primary packaging. 2. Secondary packaging.  PRIMARY PACKAGING Primary packaging materials are in direct contact with the product. This also applies to the closure which is also part of the primary pack.

 Secondary packaging are additional packaging material that

improve the appearance of the product and include outer wrappers on labels that do not make direct contact with the product. Materials Use for Packaging  The containers used for pharmaceutical products are usually made from the following materials;  Plastic  Metal  Glass  Paper and board  Rubbers

Plastic containers for pharmaceutical product are primarily made from the following polymers: polyethylene, polypropylene, polyvinyl chloride, polystyrene and to lesser extent, polyethylene methacrylate, theamino formaldehyde

Types of plastic:

Thermoplastic Type: - This type of plastic gets softened to a viscous fluid on heating and hardens again on cooling. The hardness after cooling is influenced by the degree of cross linkage or intermolecular attrition between the long chain molecules.

2. Thermosetting Type: - This type of plastic not gets softened to a viscous fluid on heating and hardens again on cooling.

Advantage of Plastic: 1. light in weight. 2. poor conductor of heat. 3. sufficient mechanical strength. 4. transported easily. 5. unbreakable. 6. good protection power. 7. resistance to inorganic chemicals.

Disadvantage of Plastic: 1. permeable to water vapor and atmospheric gases. 2. can not withstand heat without softening or distorting. 3. absorb chemical substance, such, preservatives for solution. 4. They are relatively expensive.

1. Collapsible tubes 2. Metal containers for tablets and capsules 3. Metal foil

Advantage of Metals: 1. They are sturdy. 2. They are impermeable to light, moisture, gas 3. They are light in weight as compared to glass containers 4. Labels can be printed directly on to their surface.

Disadvantage of metals: 1. They are expensive. 2. They may shed metal particles into pharmaceutical products 3. They are not generally used for extemporaneous dispensing. 4. They react with certain chemicals of drug.

Type of glass:1. Lime-soda glass 2. Borosilicate glass 3. Silicone-treated glass 4. Amber color glass 5. Sulphured glass Advantage of glass:1. Comparatively cheaper 2. They are transparent. 3. They are neutral after proper treatment. 4. Good protection power. 5. They can be easily labeled.

Disadvantage of glass 1. Glass is fragile. 2. Glass containers are heavy.

Composition:-Paper and board are composed of cellulose obtained by the mechanical or semi chemical treatment of fibers dried from various sources like wood, hemp, cotton, etc. in some case waste and regenerated paper is used.  They are used for preparing outer container such as cartons, boxes, envelopes.

 Rubbers are excellent material for forming seals so they are

used almost exclusively to form closures such as stopper (bung)for vials or in similar application such as gasket in aerosol can.  These are consist of Two types: a) Natural b) Synthetic

 Class A- Critical defects  Class B- Major Defects  Class C- Minor defects

Defects in Pharmaceutical Containers  Lack of heat seal - incomplete heat seal  Delaminations, channel voids and contaminations  Inclusions of product or foreign materials in the seal area  Misplaced lids/tops/closures or crimp seals  Invisible defects/leaks  Holes or crack defects in empty vials/ampoules

1. 2.

3. 4.


Joint or material failures are potential problem areas If the packaging material is not sufficiently strong, then failure can occur as a collapse, rupture, split, tear or crack. Closures can be another trouble spot One of the biggest sources of supermarket customer complaints is badly applied caps on some pharmaceutical packages Packaging machines often run out of gas. or the machine controls are not set correctly, thereby producing thousands of out-of-specification packages(oos).

Concept of Pharmaceutical Packaging Material
Blister packaging
Blister packs are commonly used as unit dose packing for pharmaceuticals dosage forms such as tablets, lozenges, soft and hard gelatin, drops. Blister packing is also used in the toy, hardware, cosmetic, pharmaceuticals, confectionary, and food product industries as well as in many house hold products.


In the case of thermoforming, a plastic film or sheet is unwound from the reel and guided though pre-heating station on the blister line.
– blister formed with aid

of heating – low to high barrier

Cold forming:-In the case of cold forming, an aluminum-based
laminate film is simply pressed into a mold by means of a stamp. – blister formed mechanically . – high barrier

Strip Packaging

 A Simple Tutorial

Creating and distributing a simple package really drives some of the key concepts . This tutorial shows how to create and distribute a particular type of package, called an unmanaged package.  Managed packages Managed packages add a whole range of functionality and behavior to packages

 Strip designing

Generally strips are available in very design, as the emerging units are constantly rectangular or square strips. However, the pocket portion can be round, oval or square. STABILITY OF PHARMACEUTICAL PACKAGING Medicinal and Pharmaceutical products are subject to a variety of degradation pathways that compromise drug safety and shelf-life. By far the greatest degradation is caused by hydrolysis and oxidation. Pharmaceutical Package Stability Testing  Thermal Performance Testing  Stability Testing
 Distribution Simulation.

Sterilization Methods
 Steam Sterilization
 Autoclaves  Dry Heat Sterilization  Gas Sterilization  Sterilization by Ionizing Radiation

Quality Control of Packaging
Glass Testing Powdered Glass Test Powdered glass test (As per USP): Water Attack at 121OC
Testing of Plastic Container Leakage test for Plastic Containers Water Vapor Permeability Test for Plastic Containers for Injectables Preparation Collapsibility Test for Plastic Containers

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Container-Closure Integrity Test
Package integrity is an essential requirement for maintaining the microbiological safety and quality of, for example, sterilized and modified atmosphere packed foods. The increasing focus on quality assurance is the main driving force putting demands on verification of food package integrity .

 New PVdC emulsions development allows the processor to

reduce the coating mass of PVdC to attaining the equivalent barrier of previously standard coating weights available (such as a 20 gms/m2 offering equivalent barrier to a standard 40 gms/m2 coating).  Aclar film laminate with PVC: has found a growing market In new drug delivery systems such as controlled/sustained release and especially rapid dissolve system(offer WVTR0.08 g/m2).

 Cyclic Olefin Copolymers (COC)

are providing the enduser with exciting new alternative barrier materials for blister packaging. COC is free of chlorines, halogens and fluorines Available in a number of laminations COC can be combined with a range of substrates such as PP; PVC; PET. COC films offer excellent barrier and process performance.

(PVC/PCTFE/PVC) High Barrier Films • Designed to thermoform in the same operating range as PVC mono film. • High moisture barrier after thermoforming, as compared to standard two-layer PVC/PCTFE structures.

 PVDC-coated PVC films for improved barrier.

Most common structures: • PVDC/PVC duplex • PVDC/PE/PVC triplex
 WVTR @ 120 g/m² = 0.16 g/m²·d at 40oC, 75% R.H.  New PVDC latex for pharmaceutical packaging, e.g.

New DIOFAN super B PVDC latex having • WVTR @120 g/m2 of 0.08 is 1/2that of standard grade. • OTR @ 120g/m2 of 0.1 cm3/

 Nanocomposites technology • Nanocomposites are polymer structures that contain fillers,

typically silicate nanoclays, with at least one dimension in the nanometer range. • Nanocomposites modified films also have improved dimensional stability and stiffness and, because crystallinity is increased, enhanced clarity. • The oxygen barrier of nylon nanocomposite films can as much as 50 percent higher than a nonmodified nylon.

Active Packaging
1. Oxygen Scavengers  When products are extremely sensitive to presence of oxygen, oxygen scavengers provide an excellent way to extend product shelf-life and ensure freshness and/or product efficacy.  Oxygen scavengers reduce the level of oxygen in the headspace of the package. Because oxygen scavengers have a finite absorption capacity,  They must be used with a passive barrier.  Two types of oxygen scavengers a. Ferric compositions b. Oxygen scavenging polymers

2. Moisture Scavengers  Moisture scavengers are created by incorporating a

desiccant into a polymer layer  The choice of the desiccant is dependent upon the end humidity desired.  If the goal is to maintain the humidity at a specific level, hydrate forming salts are used. These salts will not absorb water until the relative humidity at which the first hydrate forms is reached.

 The future aspects of the packaging technologies ensure the

product safety, reliability, ingredient information which all compiles the integrity of the finished product as well as the marketed value of the company and the product.  Newer trend provides the future technology in the field of marketing as well as in the pharmaceutical field, by this forthcoming generation can get benefits from this.

Thomas W [11] studied unmanaged packages that can be used for a one-time distribution, like a template. These are ideal for sharing application templates or code samples. For example, the package created in the tutorial was an unmanaged package.” Wheaton, I.L. [12] studied the different type of plastics. Plastics are synthetic polymer of high molecular weight. Plastic is made from one or polymers together with certain additives. The polymers commonly used as polyethylene, polypropylene, polyvinyl chloride, polystyrene, polymethyl acrylate.” Keitch L. smith [13] studied that the primary consideration for the design of a blister relies within the customer’s need for strength and consistency within the part.

Wilmington, DE[14] studied 3-D SMART™ Product Suite for Blister Packaging 3-D Scanning and drawings™ technology uniquely connects package design with production reality to establish a standard engineering design policy for pharmaceutical blister packaging Montesano Associates, LLC and Prodieco Pharmaceutical Components today released a suite of products based on their new 3-D SMART™ technology. 3-D SMART™ combines 3-dimensional scanning. E. Swain et.al15 studies on PVC material are used as supporting material for the blister packing PVC is present in hard form and its strength and superior resistance to sterilization effect. Bacon, F. R. et al. [16] stability studies for products stored in impermeable containers can be conducted under any controlled or ambient humidity condition. Albert[17] studied the two primary components of a blister packs are the cavity or pocket made “formable” web either plastic or aluminum and the leading, made from paper, cartoon. The product and the leading seal the product in the package

Paul H. Joe. H. [18] Studies that Blister pack is a term for several types of pre-formed plastic packaging used for small consumer goods. Blister packaging is an inexpensive option for creating packages that are durable, transparent, and tamper proof. Zahn M. et al. [19] a risk-based approach to establish stability testing conditions for tropical countries. Journal of Pharmaceutical Sciences 95:946-965. Kenneth C. [20] a guide for stabilization of pharmaceuticals to oxidation is presented. Literature is presented with an attempt to be a ready source for data and recommendations for formulators. Liquid and solid dosage forms are discussed with options including formulation changes, additives, and packaging documented. In particular, selection of and methods for use of antioxidants are discussed including recommended levels.”