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Primary and secondary packaging of pharma products

Piyush Tripathi
Thursday, October 17, 2013, 08:00 Hrs  [IST]

The primary and secondary packaging of pharmaceutical products is closely linked to their production and constitutes an integral part of the value-added process. The quality control unit is responsible for the control of pharmaceutical packaging materials including their receipt, identification, sampling, testing, and approval or rejection of drug product containers and closures. The responsibility for the tests lies now more and more with the manufacturers of packaging materials. However, as a precondition for this, additional QA measures, like vendor qualification, supplier audit and technical agreements, have to be taken.

The Federal Food, Drug, and Cosmetic Act mandates the need for adequate information related to packaging materials. Section 501(a)(3) of the Act states that a drug is deemed to be adulterated, if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health. In addition, section 502 of the Act states that a drug is considered misbranded if there are packaging omissions. Also, section 505 of the Act requires a full description of the methods used in, and the facilities and controls used for, the packaging of drugs. Section 505(b)(1)(D) of the Act states that an application shall include a full description of the methods used in, the manufacturing, processing and packing of such drug. This includes facilities and controls used in the packaging a drug product.

Primary packaging means any single part of a container closure system. Typically containers (e.g. ampoules, vials, bottles), container liners (e.g.... tube liners), closuree.g.g.g.g. screw caps, stoppers), closure liners, stopper overseals, container inner seals, administration pe.g..g..g..g on large-volume parenterals (LVPs)), overwraps, administration accessories, and container labels. A primary packaging component means a packaging component that is or may be in direct contact with the dosage form. A secondary packaging component means a packaging component that is not and will not be in direct contact with the dosage form.

Standard on containers and closures
Current good manufacturing practice (cGMP) requirements for the control of drug product containers and closures are included in 21 CFR Parts 210 and 211. A listing of the relevant sections is provided in Attachment A. In addition, a listing of compliance policy guides that deal with packaging issues is provided in Attachment B. References in this guidance to CGMP regulations are provided for completeness.

The FDA requirement for tamper-resistant closures is included in 21 CFR 211.132 and the Consumer Product Safety Commission (CPSC) requirements for child-resistant closures are included in 16 CFR 1700. An outline of these and other applicable regulatory requirements is provided in Attachment A. Sterilization packaging systems are classified as Class II medical devices and require a 510(k) for their intended use to be legally marketed. Manufacturers of sterilization packaging systems must submit a Premarket Notification 510(k) Submission to the FDA prior to marketing their product. The submission includes a completed application, extensive data, documentation of testing and validation studies, special labelling, intended use, and instructions for use.

The United States Pharmacopoeia Convention has established requirements for containers which are described in many of the drug product monographs in The United States Pharmacopoeia/ National Formulary (USP/NF). For capsules and tablets, these requirements generally relate to the design characteristics of the container (e.g. tight, well-closed or light-resistant). For injectable products, materials of construction are also addressed (e.g. Preserve in single-dose or in multiple-dose containers, preferably of Type I glass, protected from light). These requirements are defined in the General Notices and Requirements (Preservation, Packaging, Storage, and Labelling) section of the USP. The requirements for materials of construction are defined in the general chapters of the USP.

Many active drug substances are susceptible to degradation or loss of potency

  • Light
  • Aluminium, ambered glass/plastic
  • Humidity
  • Barrier films, aluminium, blister packaging
  • Oxygen
  • EVOH ((ethylene vinyl alcohol copolymer) barrier films
  • Ensure dose levels are constant
  • Metering packaging
  • Minimise physical damage to solid dosage forms
  • Limit contamination of multiple dosage forms
  • No risk from Extractable and Leachable
  • Tamper evidence
  • Assurance that the consumer has unadulterated product
  • Patient comfort and security
  • Ease of use by the customer (especially elderly)
  • Prevention of misuse-children and accidental
  • Reduced risk of injury
Classed by the proximity of packaging to the drug:
  • Primary packaging
  • Contains the drug product
  • Packaging components that are in direct contact with the drug formulation.
  • Functional packaging
  • Packaging that is used in the function of delivery of the drug or dispensing, or effect the overall performance of a delivery device
  • Secondary packaging
  • Packaging components that help to protect the product
  • Foil wraps and labels
The prime functions for effective packaging systems are to:
  • Permit sterilization of the package contents
  • Maintain sterility of the contents until the package is opened
  • Permit aseptic presentation of the package contents
Several essential performance characteristics of packaging include:
  • Ability to withstand physical conditions of the specific sterilization process
  • Adequate air removal; sterile penetration and contact with the contents; and evacuation of the sterile.
  • Free of toxic materials or dyes; and be low-linting.
  • Adequate barrier to micro-organisms and environmental contaminants
  • Durability to resist tears and punctures
  • Removal of the contents without contamination.
  • Additionally, packaging systems should be easy to use and cost-effective.
Packaging documentation includes aspects related to:
  • Specifications and quality control, including batch records;
  • Labels, inks and adhesive materials (e.g. glue);
  • Package inserts for patients.
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. It may be very useful in improving compliance with treatment and may also be useful for less stable products.
  • 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.

Glass containers are classified according to their hydrolytic resistance

Type I Glass
Neutral glass, with a high hydrolytic resistant due to the chemical composition of the glass itself. Suitable for most preparations whether or not for parenteral use.

Type II Glass
Usually of soda-lime-silica glass with a high hydrolytic resistance resulting from suitable treatment of the surface. Suitable for most acidic & neutral aqueous preparations whether or not for parenteral use.

Type III Glass
Soda-lime glass usually of soda-lime-silica glass with only moderate hydrolytic resistance. Generally suitable for non-aqueous preparations for parenteral use, for powers for parenteral use (except for freeze-dried preparations) and for preparations not for parenteral use.

Note: Except for type I glass containers, glass containers for pharmaceutical preparation are not to be re-used.

Rubber closures
Rubber consists of several ingredients, one of which is elastomer. Modern rubber compounds used in packaging pharmaceuticals contain only limited number of ingredients, which are very difficult to extract. Closures made from such materials generally do not pose any problems, and can be used in contact with large number of drug preparations.

Rubber closures for pharmaceutical use must meet the relevant requirements of the most important pharmacopoeias. It should be emphasized that the requirements of pharmacopoeias and standards must be seen as minimal requirements. The suitability of a rubber closure for a given application can only be established by means of stability studies.

Apart from monitoring and record controls of primary packaging selection criteria of the same are defined in pharmacopoeia and standard documents which are to be a part of daily acceptance practices. For any process and selection of packaging material it’s a must to validate the process requirements and product requirements. Various studies related to the same are available, selection of guidelines to be followed is completely an individual and process choice.

(The author is a Project Manager,
Sagar Rubber Products Pvt Ltd , Mehsana, Gujarat)


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