PFAS

Primary packaging materials such as rubber stoppers, plungers or syringe components come into direct contact with medicines and influence their stability and purity. The specific requirements for these packaging components are

- Chemical resistance: No leaching of substances into the medication.

- Sterility: Ability to withstand high temperatures and sterilization processes.

- Inertness: No interaction with sensitive active pharmaceutical ingredients.

- Tightness: Reliable protection from air, moisture or contaminants.

PFAS are used in these applications because they have exceptional chemical and mechanical properties that meet these requirements.

Use of PFAS in primary packaging

Rubber stoppers:

Rubber stoppers are often used for glass vials (vials) containing sterile drugs such as vaccines, biologics or liquid dosage forms. PFAS are used here in the form of coatings or additives:

- Coatings made of PTFE (polytetrafluoroethylene): These reduce friction and prevent the stopper from sticking to the glass surface.

- Barrier function: PFAS layers prevent the leaching of additives from the rubber (e.g. vulcanizing agents) into the medication.

Plunger:

Plungers are used in pre-filled syringes, auto-injectors and pens. Their tasks are precise dosing and the prevention of contamination. PFAS are used in these components to:

- Low friction movements: A PTFE coating or fluorinated polymers reduce friction between the plunger and the syringe wall, allowing for smooth drug delivery.

- Chemical stability: Fluorinated materials prevent reaction with biological or chemical drugs, especially with aggressive substances such as biopharmaceuticals.

Seals and other components:

Other components, such as rubber seals in inhalers or valve systems, also use PFAS-coated materials to ensure reliable function with minimal wear and maximum chemical resistance.

The use of PFAS in rubber stoppers, plungers and other packaging materials offers several advantages:

1. Outstanding chemical stability: PFAS coatings are virtually inert to most pharmaceutical formulations, including aggressive substances such as acids or organic solvents.

2. Minimization of interactions: PFAS prevent undesirable substances (e.g. plasticizers or rubber vulcanization products) from transferring into the drug.

3. Sterilizability: PFAS-coated materials withstand high temperatures, autoclaving and other sterilization methods.

4. Improved functionality: In applications such as prefilled syringes, they improve the maneuverability and precision of plunger mechanisms.

5. Longevity: PFAS materials are highly resistant to wear and tear, which increases the service life of packaging materials.

Despite their functional benefits, there are increasing concerns about the use of PFAS in primary packaging materials:

Migration and contamination

One potential risk is the migration of PFAS or their degradation products into the pharmaceutical product. Although PFAS are mostly used as stable coatings, minute amounts can be released, potentially compromising the safety and efficacy of the drug.

Environmental problems

During the manufacture and disposal of PFAS-coated primary packaging materials, the chemicals can be released into the environment. Their extremely long lifetime leads to accumulation in water, soil and biological organisms.

Toxicological concerns

Some PFAS compounds are suspected of being harmful to health. Although exposure via primary packaging materials is low, there are calls to avoid the use of such materials in order to completely eliminate risks.

In view of the potential risks, regulatory authorities around the world are tightening control over PFAS. Particularly relevant for the pharmaceutical industry are:

- EU regulations: The European Chemicals Agency (ECHA) is seeking a comprehensive ban on PFAS in various applications, including packaging materials.

- FDA requirements: In the US, the FDA is increasingly reviewing the safety of PFAS in materials that come into contact with pharmaceuticals.

- ISO standards: International standards for pharmaceutical primary packaging materials may become more stringent in the future to limit the use of PFAS.

These regulatory changes are forcing the pharmaceutical industry to develop alternatives to PFAS while meeting the stringent requirements for packaging materials.

The search for environmentally friendly alternatives to PFAS is one of the biggest challenges facing the pharmaceutical industry. Approaches include:

1. Fluorine-free polymers: Developing novel polymers that offer similar barrier and friction properties.

2. Ceramic coatings: Use of ceramic or other inorganic coatings that are inert and more environmentally friendly.

3. Improved rubber formulations: Optimization of rubber materials that do not require fluorinated additives.

4. Recycling and circular economy: Reuse of PFAS-containing materials to minimize environmental impact.

PFAS are indispensable in the pharmaceutical industry, especially for primary packaging materials such as rubber stoppers and plungers, as they offer exceptional chemical stability, inertness and functional advantages. However, the risks posed by their persistence and potential toxicological effects are increasingly bringing their use to the forefront of regulatory and societal debates. The industry is faced with the urgent task of developing sustainable alternatives that take into account both functional requirements and environmental aspects. However, the transition to a PFAS-free future in primary packaging requires significant investment in research and development and close collaboration between academia, industry and regulators.