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Safety in Mind: Pharmaceutical Packaging

Updated on July 18, 2014

Investing in Packaging for Pharmaceutical Manufacturers

The pharmaceutical industry represents an enormous portion of the U.S. economy. In 2013, consumers spent $329 billion on medications, upon which many individuals rely on to stay healthy and functional.

When people visit physicians, pharmacies, or other drug-dispensing facilities, they depend on these entities to provide them with medications that produce the effects described by the manufacturer. Although taking prescribed drugs always carries risk of side effects, consumers expect the pharmaceutical industry to engage in responsible practices to keep customers safe. One way drug companies do this is by investing a great deal in packaging.

Pharmaceutical Packaging Equipment

WWhy is Pharmaceutical Packaging So Important?

According to the World Health Organization (WHO), packaging is such an important component of pharmaceuticals that manufacturers should consider the two together as a complete product. This may come as a surprise to end users, but the delicate chemical balance required for medications to work correctly depends in part on the container in which they are stored.

When manufacturers fail to package, seal, and store drugs properly, devastating effects can result, including reduced drug efficacy, infection, and death. Therefore, numerous regulatory agencies have provided strict requirements for how companies may store and ship pharmaceuticals.

To understand the multifaceted process of medicinal packaging, individuals must familiarize themselves with the existing guidelines regarding this important topic.

Considerations for Compliant Medical Packaging: What Our Systems Do Best

For drug manufacturers, producing safe and effective pharmaceuticals is merely the first step in a complex process to transfer medications from the laboratory to the consumer. The next step – packaging – presents several crucial components to which manufacturers must adhere to maintain the integrity of their products.

Characteristics for which pharmaceutical companies must account in drug packaging include:

  • Function. The design and construction of a pharmaceutical package must always provide an airtight, contamination-proof, damage-resistant structure free from the risk of altering a medication’s formulation or dosage. It should also come in a shape and form that complements the method of administration. Our packaging systems can handle bagging, airtight-sealing, and more.
  • Materials. Depending on the type of medication, a pharmaceutical container may consist of various forms of glass, plastic, or metal. Each material offers its own benefits and levels of durability, impermeability, weight, and other qualities. Packaging with our systems can be done with any of these FDA-required materials.
  • Testing. Regardless of the materials used, the product must undergo rigorous testing to measure factors such as stability, compatibility, and interactions with the drugs they will eventually contain.
  • Filling and assembling. Manufacturers must carefully design and monitor the processes by which they fill pharmaceutical containers to ensure accurate quantities and prevent contamination before affixing closures. An innovative, detail-driven packaging system is guaranteed great consistency and reliable results.
  • Sterilizing. Throughout the packaging process, every tool and component that touches the medication or its container must remain free from contamination. Even the smallest amount of a seemingly harmless foreign substance may be enough to destroy a batch of pharmaceuticals. We specialize in medical and pharmaceutical packaging systems that can ensure best practice and sterilization compliance.
  • Storing and stabilizing. Temperature, ventilation, lighting, humidity, and shelf life all present crucial considerations for maintaining the integrity and safety of pharmaceuticals.

Understanding the Rules and Regulations behind Pharmaceutical Packaging

Under the Code of Federal Regulations – Title 21, the U.S. Food and Drug Administration (FDA) provides a list of best practices for companies that produce packaging for finished pharmaceuticals. These guidelines encompass each step of the packaging development process, including:

  • Pre-testing. Testing facilities must place containers in quarantine storage prior to testing them to prevent false results caused by contamination or other environmental effects.
  • Testing. Each lot of packaging materials must undergo a rigorous review, during which testers examine each component of a package using aseptic techniques and sterile equipment. The quality, strength, and purity of the drugs within the containers must meet written specifications for these medications. Additionally, the packaging and its closures must operate correctly as indicated by the manufacturer. Our systems, modern and steadfast, ensure fewer fallacies in closure or design.

  • Approval or rejection. Based on the results of testing, a grouping of packaged medications may be approved or rejected for release to retailers. Approved drugs may be retested or released into the market; rejected drugs are subject to quarantine and must be labeled as such. Avoid rejection by packaging with state-of-the-art equipment.

Pharmaceutical Packaging Safety Risks Manufacturers Must Consider

As drug companies and manufacturers design and produce packaging for their products, they must account for numerous potential hazards presented by improper handling, as well as inadequate containers and filling processes. The World Health Organization (WHO) has provided a number of considerations that may negatively impact the safe and effective packaging of medications, including:

  • Contamination. When facilities, equipment, or packaging contain elements that interact with a medicine’s chemical structures, dangerous interactions may occur that reduce the efficacy of a drug or make it harmful for those who ingest it.
  • Microbial growth. Numerous microorganisms may find their way into pharmaceuticals under certain conditions, compromising the integrity of drugs and posing risks to consumers. Prevention methods against microbial growth include storage in low temperatures, dim light, and balanced humidity. Our packaging systems function well under the appropriate conditions, enabling manufacturers to guarantee that the transition from packaging to storage will be ideal for all materials.
  • Improper labeling. All drug packaging must display written labeling that identifies the product name, active ingredients, manufacturer batch number, expiration date, storage conditions, use directions, precautions, warnings, and name and address of whichever entity placed the drug on the market. Without this information, consumers face hazards such as incorrect dosage, drug interactions, spoilage, or the inability to contact the manufacturer regarding side effects. Create packaging that allows for proper labeling with an industry-suited packaging system.

  • Tampering. Manufacturers must closely monitor every step of pharmaceutical packaging design and production to prevent tampering with medications by individuals with malicious intent. Creating securely closing packages also wards off interference from outside parties once products enter the market.

Regulatory agencies such as the WHO and FDA have worked with pharmaceutical manufacturers for a long time, and as such, have witnessed the many outcomes that can result from improper design or techniques in drug packaging. By following the rules and regulations these organizations have established, pharmaceutical companies draw on years of testing and development to create the safest products for their consumers. Packaging is a huge component to pharmaceutical quality and safety, and accounts for a large portion of regulation from the WHO and FDA. Innovative packaging systems can confirm that pharmaceutical companies encounter no obstacle to meeting or exceeding packaging standards.

Where Do Companies Turn for Safe, Quality Pharmaceutical Packaging?

Pharmaceutical manufacturers invest a great deal of time and resources in the development and production of cutting-edge medications to treat individuals’ health problems. By trusting quality contractors to follow the many guidelines governing the pharmaceutical industry, they ensure their products remain safe and effective until they reach the hands of consumers.

Technical Packaging Systems, Inc. is committed to producing pharmaceutical packaging systems that meet or exceed industry expectations. These systems allow pharmaceutical companies to adhere to quality and safety standards through the use of efficient and reliable equipment. For more information about our packaging services, contact us today.


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