The growing need for reliable and safe pharmaceutical products has led to the continuous development and improvement of medical devices used in drug delivery systems. One such innovation is freeze-drying closures for infusion bottles, designed to preserve the quality and stability of pharmaceutical products. Indian Standard IS 18879 (Part 6): 2024, specifies the design, material and performance requirements of these enclosures. These closures play an important role in ensuring the stability, safety and effectiveness of freeze-dried pharmaceutical preparations. By preventing exposure to contamination and moisture during storage and transportation, they play an important role in maintaining the quality of medical products.

--------------Blog Contact Form-------------

What is IS 18879 (Part 6): 2024 ISO 8536-6: 2016 Infusion Equipment for Medical Use Part 6 Freeze Drying Closures for Infusion Bottles?

IS 18879 (Part 6): 2024 Indian Standard which is identical to ISO 8536-6: 2016 ‘Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles’ issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on the recommendation of the Hospital Equipment and Surgical Disposable Products Sectional Committee and after approval of the Medical Equipment and Hospital Planning Division Council. 

These closures are essential components in the freeze-drying (or lyophilization) process, which is used to dry pharmaceutical and biological materials. The standard ensures that closures are made of materials capable of withstanding sterilization and maintaining their functionality under harsh conditions, such as exposure to high temperatures and humidity. The standard covers essential aspects such as material selection, dimensions, design features, and performance requirements, including the ability to withstand moisture, chemical exposure, and mechanical stress during storage, transportation, and sterilization.

Significance of IS 18879 (Part 6): 2024

Adoption of IS 18879 (Part 6): 2024 is of great importance in the pharmaceutical industry, especially in ensuring the integrity and stability of freeze-dried drugs. Freeze-dried products are highly sensitive to moisture, and even small amounts of moisture in the closure material can compromise the quality of the drug. 

This standard addresses this concern by specifying requirements to reduce residual moisture content in the closure, thereby ensuring preservation of freeze-dried product efficacy. The standard also helps pharmaceutical companies and medical device manufacturers meet current good manufacturing practices (cGMP), which ensure that closures are formulated with high-quality materials and maintain sterility and stability throughout their shelf life.

Also Read: IS 18853: 2024 ISO 11978: 2017 + AMD 1: 2020 Ophthalmic Optics - Contact Lenses and Contact Lens Care Products Labelling

Scope of IS 18879 (Part 6): 2024 

IS 18879 (Part 6): 2024 is a standard that sets guidelines for closures used with infusion bottles, particularly for freeze-drying drugs. It covers the design, size, and materials of the closures to ensure they fit properly and work well. The materials must be strong enough to handle sterilization and reduce moisture. The closures must also pass tests for durability, such as resistance to breakage and the ability to withstand punctures. Additionally, the closures must be clearly labelled to show they meet the required standards. However, these rules don't apply to barrier-coated closures, which are designed for special uses requiring extra protection against environmental factors.

Key Components of IS 18879 (Part 6): 2024 

The standard provides clear guidelines on the essential components and features of the freeze-drying closures. These include: 

1. Shape and dimensions 

The closures should adhere to precise dimensions for compatibility with infusion bottles. The key dimensions specifies the nominal size, diameters, and heights of different closures. This ensures that the closures fit securely and maintain the integrity of the freeze-drying process. 

2. Material requirements 

The closures are made of elastomeric materials designed to withstand sterilization cycles, especially steam autoclaving. The material should exhibit a strong barrier function against moisture and gases to maintain the quality of the pharmaceutical products during storage. Commonly used materials include butyl rubbers, known for their excellent moisture resistance.

3. Performance features

• Spike penetration force: The closure must be able to withstand the force of a piercing device (spike) without leakage or distortion.
• Fragmentation resistance: The closure should not fragment when pierced, as this could lead to contamination of the pharmaceutical product.
• Sealability: The closure must provide an effective seal to prevent leakage during storage, transport, and use.

4. Moisture control

The standard emphasizes the importance of controlling residual moisture within the closure material. This is achieved through testing methods that ensure the closures are adequately dried during the manufacturing process. The Karl Fischer method is used to determine the residual moisture content, ensuring that moisture levels are minimized to prevent the degradation of the freeze-dried products.

5. Labelling

Closures that meet the requirements of this standard must be clearly labelled to indicate compliance. This ensures transparency and allows users to identify closures that are safe and effective for their intended use.

Benefits of IS 18879 (Part 6): 2024

The IS 18879 (Part 6): 2024 standard offers many benefits to manufacturers, healthcare providers, and patients. These include:

• Increased product stability: By ensuring that closures are made of high-quality materials and meet specific performance criteria, standards help maintain the stability and efficacy of freeze-dried drug products even during storage and transport.
• Improved quality control: The standard promotes rigorous quality control procedures, ensuring that each closure meets the required specifications for performance, moisture content, and material composition. This reduces the risk of defects and ensures consistent product quality.
• Patient safety: By preventing contamination and ensuring that freeze-dried products remain free of moisture, closure helps maintain the safety and effectiveness of medications. This directly helps patient outcomes and reduces the risk of treatment failure.
• Regulatory compliance: Standards help manufacturers comply with good manufacturing practices (GMP) and international regulations. This ensures that pharmaceutical companies meet the necessary legal and safety requirements, allowing them to access international markets with confidence.
• Cost efficiency: While standards ensure high-quality closures, they also provide manufacturers with clear guidelines for cost-effective production. By reducing defects and improving manufacturing efficiency, standards help reduce waste and optimize production costs.

Also Read: IS 18929 : 2024 Textiles - Synthetic Filament Yarns - Electrostatic Propensity Evaluation by Measuring Electrical Resistance (ISO 24180 : 2021, MOD)

Impact of IS 18879 (Part 6): 2024 on Stakeholders

IS 18879 (Part 6): 2024 affects various stakeholders in the pharmaceutical industry:

• Manufacturers benefit from clear specifications that guide production, ensuring high-quality closures that meet regulatory standards. This increases their reputation and regulatory compliance.
• Pharmaceutical companies rely on quality to ensure the stability and safety of freeze-dried drugs. Doing so reduces the risk of product returns due to contamination or quality issues.
• Healthcare providers benefit from reliable closure systems that maintain drug stability during storage and reconstitution, ensuring safe and effective treatment for patients.
• Regulatory authorities are supported by this standard, which ensures that only safe, effective medicines are approved while supporting public health initiatives.
• Patients ultimately benefit from quality through safe, effective and stable medicines, as closures prevent contamination and degradation, and contribute to better health outcomes.

Other Important Considerations of IS 18879 (Part 6): 2024

While the standard outlines comprehensive requirements for freeze-drying closures, manufacturers must also consider factors such as supply chain logistics and storage conditions. Closures should be stored and transported under conditions that prevent absorption of contamination and moisture. Additionally, manufacturers must keep up with the latest advances in sterilization techniques and material sciences to ensure that closures remain effective as production processes evolve. Testing methods should be reviewed periodically to ensure compliance with the latest industry standards and regulations. They need BIS certification for further processing and to gain consumer confidence.

Conclusion

The IS 18879 (Part 6): 2024 standard plays a crucial role in ensuring the quality, safety, and stability of freeze-dried pharmaceutical products. By specifying the design, materials, performance criteria, and testing methods for freeze-drying closures, the standard supports the production of high-quality infusion equipment that meets both regulatory requirements and customer expectations. The adoption of this standard benefits all stakeholders in the pharmaceutical supply chain, from manufacturers and healthcare providers to patients and regulatory authorities.