Guidelines on Packaging for Pharmaceutical Products

Introduction

Packaging bottles play a significant role in the successful distribution of pharmaceutical products. This article describes the factors that must be considered when choosing packaging materials for pharmaceutical products and presents recommendations on how to package them.

General

A pharmaceutical product is a drug that can be used to diagnose, cure, treat or prevent disease in humans.

A primary package is an immediate container in which a drug substance or drug product is presented for sale at retail and professional use. The term includes any overpacks. An overpack is an inner pack fitting into another outer pack (primary package) which itself may be surrounded by further layers of packaging, such as cartons or corrugated board.

A secondary package refers to several drugs packed together at the same time but enclosed in a different type of outer container from that in which they were originally marketed and supplied (for example, tablets sold loose inside cardboard boxes).

Tertiary packaging means moving packaged goods from one form of transportation to another (from trucks to trains etc.).

Storage Conditions

As you may know, the packaging is the most important piece of your product. It’s what keeps the product safe and secure during its journey from production to consumer. To ensure that your product maintains its quality over time, you will want to carefully consider how it should be stored.

The type of packaging used for a pharmaceutical product can affect its storage conditions as well. For example:

• A plastic bottle could be stored at room temperature with no special precautions needed.
• An aluminum foil pouch would need refrigeration or freezing to maintain freshness and potency over time (depending on the contents).

Sterilization Methods and Requirements

• The methods and requirements for sterilization are:
• Gamma radiation: 2.5-3.0 Mrad or more
• EO gas: 21,000 mg/L or higher (equivalent to 20% ethylene oxide)
• Requirements of the packaging materials
• Glass ampoules need to be sterilized by gamma radiation with a dose of at least 3 Mrad (300 kGy), or an EO gas concentration of 20%, before filling them with liquid products. This is because glass is generally not porous and does not absorb liquids easily.
• Packaging facility requirements are as follows:

Types of Glass Containers

• Types of glass containers

There are several types of glass containers that can be used for packaging pharmaceutical products. They include:

• Aseptic vials (glass or plastic) with rubber stoppers and a metal cap
• Double-wall glass vials with metal caps (metal-to-metal closure)
• Screw-top bottles, including bottles with diaphragms, flip tops, and trigger sprayers
• Plastic ampoules (also called syringes) made from polyolefin or polypropylene, which are often used in injectable products

Labeling of Primary Packages

The label should be placed on a conspicuous part of the primary package. For example, it can be affixed to the top or bottom of the container. It should be legible and easy to read with indelible ink that will not smear or rub off when wet.

The label must also include:

• Name, strength, and dosage form of product;
• Name and address of manufacturer, packer, or distributor;

Labeling of Secondary and Tertiary Packages

The secondary and tertiary packages should contain labels with the following information:

• Name of the drug, if applicable, and national drug code (NDC) number
• The name and contact details of the manufacturer or packager.
• Date of manufacture or packaging
• Lot number.

Product Information Leaflet and Patient Information Leaflet

The product information leaflet (PIL), also known as a patient information leaflet, is required by law for every pharmaceutical product. It is written for the patient or their caregiver and explains how to use the medicine correctly. The PIL should include:

• All relevant safety and usage information
• Information on interactions with other medicines or foods
• Details on storage conditions

The patient information leaflet should be written in clear language that can be understood by all people who will potentially read it. It must explain in detail why your medicine is necessary, any potential side effects or risks of using your medicine, and what symptoms to watch out for if you have any concerns about taking the medication. In certain situations where someone might need specific advice about taking their medication safely (such as patients with kidney problems), additional instructions may be added to these documents; however, this does not change the requirement for having these documents available when dispensing pharmaceutical products at pharmacies.

Clinical Trial Materials

• Clinical trial materials are the samples used during clinical trials to study new drugs or other pharmaceutical products.
• Requirements for clinical trial material packaging vary from country to country, but the general rule is that it needs to be tamperproof, provide a means for identification of contents and intended use, and be able to withstand handling during transit.
• Clinical trial materials can be packaged in primary or secondary packaging depending on their nature. Primary packaging refers to all containers that hold a product together such as bottles and boxes; whereas secondary packaging refers to any additional containers added around primary ones such as shrink wrap or a cardboard box over glass bottles in another cardboard box.

The above information will help guide the process of packaging pharmaceutical products.

The above information will help guide the process of packaging pharmaceutical products.

• You will learn about the different types of packaging materials used in pharmaceutical product packagings, such as plastic bottles and blister packs.
• You will also learn about the different types of packaging containers, which are often made from glass or plastic materials. These containers may be filled with liquid or powder substances that can then be sealed to keep them fresh until they are ready to be consumed by someone who needs them. The following diagram illustrates some common container shapes:

Containers for Pharmaceutical PackagingThere are many types of containers that can be used for pharmaceutical product packaging, but there are a few key characteristics that all good ones share:

Conclusion

It is important to note that the above information will help guide the process of packaging pharmaceutical products. It should also be noted that there are specific guidelines for different types of products and packaging materials.