Gases are utilized during the pharmaceutical production process as excipients or ‘invisible helpers,’ coming into contact with products as inerting agents. The quality of these gases increasingly garners the attention of GMP (Good Manufacturing Practice) inspectors.
Commonly used gases in the pharmaceutical industry include:
- Nitrogen for inerting or flushing
- Air for flushing
- Oxygen for fermentation
- Carbon dioxide for extraction and purification
Testing these gases presents a significant challenge for the industry as it necessitates:
- Dedicated analytical equipment compliant with pharmacopeia standards, alongside appropriate qualifications
- A dedicated sampling method
- Trained and qualified technicians, with a special emphasis on safety and security issues, given that quality evaluations should be conducted at the point of use, necessitating access to classified areas.
In addition to pharmacopoeia specifications, gases should also be tested for specific contamination and biocontamination, adhering to the general rule that the contamination level of the gas should not exceed that of the room in which it is used.
Quercus has developed a comprehensive suite of methods, complete with all necessary equipment, to perform all required tests for evaluating the quality of gases and for qualifying the pipework in the pharmaceutical industry.
We employ bags that are suitable for storing and transporting gas samples to our QC lab. These bags offer a simple, cost-effective, and efficient method for sampling. We also assist with connecting to your internal gas systems as needed.
Once received in the laboratory, samples from the bags can be analyzed using the Gas Chromatographic system, which is qualified and validated to assess the pharmaceutical compliance of your gases.
