Categories News

Compressed gas systems in aseptic production


In the world of aseptic drug manufacturing, supply reliability and safety are of utmost importance. Utilities can be divided into two main types: Process systems And Process support systems. While process support systems have no direct impact on product quality or patient safety, process systems are critical because they interact with products or essential materials. One of the most important process systems in this context is compressed gas.

Compressed gas systems in aseptic manufacturing, including air, nitrogen, carbon dioxide and gaseous hydrogen, play a crucial role in various phases of pharmaceutical processes. Therefore, it is important to understand and manage the risks associated with these systems to maintain product quality and ensure compliance with Good Manufacturing Practices (GMP).

How compressed gas systems work

Compressed gas systems use a compressor to reduce the volume of the gas, which in turn increases its pressure. This process converts mechanical energy into pneumatic energy, allowing compressed energy to be delivered through distribution lines and filters.

A well-designed compressed air system typically includes:

  • compressor: The core component that pressurizes the gas.
  • Condensate separation system: Removes moisture from compressed air.
  • Water separation system: Additionally ensures dryness.
  • filter: Particulate and coalescing filters that remove impurities.
  • dryer: Refrigerator dryers help regulate humidity.
  • Tanks and valves: For gas storage and flow control.
  • Sampling points: Critical for quality monitoring.

These systems can be generated on site or delivered in portable tanks from qualified suppliers.

The importance of risk assessment

Conducting a risk assessment of compressed gases is essential in a GMP environment. It allows manufacturers to document the design and use of these systems while determining their criticality. Here are the top reasons to prioritize this review:

  1. Prevent contamination: Proper design, qualification and maintenance help prevent contaminants from affecting product quality, stability and effectiveness.
  2. Ensure compliance: Regulatory authorities require that all supply systems, including compressed gases, meet strict quality standards. Risk assessments help demonstrate compliance.
  3. Improve process efficiency: Understanding the potential risks associated with the use of compressed gas allows manufacturers to optimize processes and improve overall efficiency.

Compressed air in pharmaceutical processes

Compressed air is commonly used in various pharmaceutical applications such as:

  • Packaging and bottling: Cleaning and moisture removal from containers.
  • Pneumatic transport: Assisting with material transportation during manufacturing.
  • Direct product contact: Used in processes such as mixing, granulating, drying, pressing, coating and packaging of tablets, capsules, ointments, creams, gels and syrups.

Given the significant role that compressed air plays in these processes, maintaining its cleanliness and integrity is critical.

Would you like to read more? Jump to other published posts in this series:

Compressed Gas Systems: Control Guidelines

or

Read the article “Compressed Gas Risk Assessment: A Significant Step in Your CCS.”



Manufacturing

More From Author