Nitrogen testing in pharmaceutical industry Applications include weighing stations process line; use of gas to maintain an inert atmosphere above a liquid or powdered product inside a storage tank, silo, reactor, fermentation and cell culturing processes, process equipment, or other vessel; use of liquid nitrogen for the preservation of biological Aug 27, 2020 · Finally, nitrogen can help maintain sterility and cleanliness of pharmaceutical products. The high-purity nitrogen protects the medicine from contacting and reacting with surrounding oxygen and moisture because it is a non-reactive gas, especially if it contains low levels of impurities. Nitrogen gas is an inert gas that is essential for a wide range of industrial processes, including electronics manufacturing, pharmaceutical production and food processing. For example, a gas used in a Grade A/ISO 5 area should not exceed the Grade A/ISO 5 maximum permitted particle limit. Nitrogen gas, used throughout the development and production stages, plays a key role in stabilizing active ingredients and extending the shelf life of products like tablets and injectables. Nitrogen can help maintain sterility and cleanliness of pharmaceutical products and control the level of oxygen in a workspace, lab or Jan 16, 2025 · Compressed air validation including tests like determination of moisture content, presence of oil content and microbial evaluation. Nonetheless, the use of nitrogen is significantly less specified than that of pharmaceutical water. To ensure the quality and compliance of pharmaceutical processes, gases such as nitrogen Jun 25, 2023 · In the pharmaceutical industry, maintaining the highest level of product quality and safety is of utmost importance. Adherence to these standards safeguards product integrity, patient safety, and regulatory compliance. With strict quality and safety requirements, the industry benefits from advanced nitrogen The actual content of the document belongs to the pharmaceutical company and based on the standard industrial practices. The retention time of the major peak in the chromatogram of the nitrogen sample corresponds to that in the chromatogram of the USP Nitrogen RS. Validation of Compressed Air Systems in the Pharmaceutical Industry The validation of a Compressed Air System in the pharmaceutical industry is typically performed according to the requirements and guidelines provided by regulatory authorities such as the International Society for Pharmaceutical Engineering (ISPE) and the United States Pharmacopeia (USP). Pharmaceutical Gas Testing The contamination of classified rooms is a real challenge for the pharmaceutical industry. 0 Purpose To lay down the procedure to monitor compressed air/gases for microbiological, non-viable particulate, oil and moisture content. Nitrogen System Qualification plays important role in pharmaceuticals. 1 Sterility test facilities have specifi c environmental requirements to ensure the integrity of tests carried out. This standard operating procedure outlines the testing of compressed air and nitrogen gas for viable counts in pharmaceutical formulations. 2. WHO good manufacturing practices (GMP) for sterile pharmaceutical products (8) requires that sterility testing should be carried out and specifi es requirements for sterility testing. Nitrogen gas is an inert gas, which protect from aerobic microbial contamination in the manufactured drug and increase their shelf Aug 25, 2017 · Testing and monitoring compressed air and other process gases, such as gaseous and liquid nitrogen, oxygen, argon, and carbon dioxide, that come into direct contact with pharmaceutical drugs during the manufacturing process is vital to assuring the quality and safety of these products. Hence, Nitrogen gas finds use in many different processes and applications, starting from basic raw material preparation, all the way to final product packaging. 2 Refer In the pharmaceutical industry, nitrogen gas is used to replace a hazardous or undesirable atmosphere with an inert dry atmosphere. It’s a core document in the pharmaceutical industry. Nitrogen has inert characteristics that lead to its ideal use as a pressurizing agent. Parameters and limits for nitrogen have to … Mar 6, 2025 · Nitrogen plays a vital role in the pharmaceutical industry, ensuring the safety, stability, and effectiveness of various medical products. Sterile pharmaceutical products should be sampled under aseptic conditions, and only when deemed absolutely essential, to avoid the risk of loss of sterility. Jan 27, 2025 · Conclusion Pharmaceutical-grade nitrogen is an indispensable resource in the pharmaceutical industry, with stringent specifications and rigorous testing ensuring its quality. Its inert nature makes it invaluable for applications where preventing oxidation or contamination is critical. Objective: To lay down a procedure for microbiological analysis of compressed air and Nitrogen. Microbial contaminants found in the compressor or compressed air lines can be devastating to a final product in these industries. With any new system creation, addition, or change, a validation should be performed to ensure the compressed air is of appropriate quality for its intended use. One of the most effective and industry-accepted approaches to mitigating oxidation risk is the use of nitrogen flushing. Nov 11, 2017 · The major components of compressed air are nitrogen, oxygen, and water vapor, so total atmospheric pressure is composed of the partial pressures of these three gases. First, let us understand the characteristics of Nitrogen and why it is used. May 11, 2024 · Eurofins BioPharma Product Testing's network of laboratories have developed the full set of methods with all the dedicated equipment to perform all the tests required for the evaluation of the quality of the gases and the qualification of the pipe works for the pharmaceutical industry. Find out how nitrogen gas improves quality in pharmaceutical product packaging, area blanketing and laboratory processes. 3. SGS is a world leader in tests for pharmaceuticals and works with the top 20 pharmaceutical companies. Mar 3, 2022 · Compressed air systems are a critical component of many pharmaceutical manufacturing facilities. These are provided as a guideline for those involved in the validation of ABC Pharmaceutical. the liquid medium pharmaceutical water, they are much less explicitly specified. Pharmaceutical users have … Validation steps for 99% USP grade Nitrogen: USP monograph review, testing criteria, method selection, and regulatory compliance. Dec 11, 2020 · The pharmaceutical industry uses high-purity grades as a shield gas for some medications. There is an increasing interest in monitoring the use of gases such as compressed air, oxygen, nitrogen and carbon dioxide – considered as excipients – and SGS gas analysis in pharmaceutical production services aim to make it easier for clients to meet regulations. May 25, 2023 · The ISO 8573-1 guidance specifies purity classes of compressed air with respect to particles, water and oil, independent of the location in the compressed air system at which the air is specified or measured. The subject of the 2007 revision of the guideline (rev 1) was the addition, as annex 1, of the CHMP Safety Working Party recommendation on non-clinical safety requirements for old medicinal gases. 4 Sterility test facilities 2. Compressed air is a critical utility used widely throughout pharmaceutical manufacturing processes and it is used both directly and indirectly with pharmaceutical products. Some of these applications include: process air, control valves and cylinders, material handling, air curtains, product drying and many other uses. Approval of this Master Plan neither provides approval of these test functions and acceptance criteria nor does it limit the test functions and acceptance criteria included in any Oct 1, 2015 · Compressed gas sampling for microorganisms is an important part of contamination control assessment. Feb 13, 2025 · Some pharmaceutical applications use pressure swing adsorption (PSA) technology to produce consistent purity levels. May 10, 2017 · Nitrogen often comes in contact with a product during manufacturing and is therefore relevant for its quality, especially when it comes to the manufacture of sterile products. Pharmaceutical is a very diverse industry. Much more: The official opinion on the assessment of GMP obligations for compressed air systems was published in the "Aide memoire - Monitoring of Sterile Manufacturers" of the Central Jun 2, 2023 · Learn how to determine the nitrogen content in Pharmaceutical ingredients. Dependable solutions CompAir have been providing compressed air technologies for a variety of applications within the Pharmaceutical Industry. The tools for sampling non-uniform materials are more complicated and more difficult to clean. Responsibility: Quality Control and Quality Assurance Department. 4. This paper addresses topics related to microbial assessment of compressed gases. Jul 29, 2020 · This fact has been taken into account as a trend in the recent months in the course of official inspections. One critical component in ensuring these standards is the use of high-purity nitrogen gas Identification— Prepare a gas chromatograph as directed in the Assay, and inject USP Nitrogen RS and the nitrogen sample into the gas chromatograph. Oct 30, 2020 · Like the food packaging and chemical industries, the pharmaceutical industry also relies on nitrogen for various applications. 0 Responsibility Trained QC – Microbiology A nitrogen plant is an essential component of the pharmaceutical industry, as nitrogen gas is often required in various processes such as packaging, purging, and inerting. Nitrogen can help maintain sterility and cleanliness of pharmaceutical products and control the level of oxygen in a workspace, lab or May 31, 2018 · Compressed air, also referred to as process gas, is used in many capacities in the pharmaceutical industry. 11 See the ICH guidance for industry Q10 Pharmaceutical Quality System and the guidance for industry Quality Systems Approach to Pharmaceutical CGMP Regulations. The ISPE Good Practice Guide for process gases asserts that compressed air usage in pharmaceutical manufacturing should be free from contaminants and routinely maintained Jan 13, 2024 · The multifaceted applications of nitrogen in the pharmaceutical industry underscore its importance in drug manufacturing, preservation, and research. Contact us to install onsite nitrogen generators at your facility. Indeed, gases are used during the production process as an excipient or “invisible helper” in Aug 29, 2024 · This chapter provides a summary of the key validation test functions and acceptance criteria for each utility system. Learn about the benefits of using nitrogen in pharmaceutical processes, the working principle of PSA nitrogen generators. 0 Scope Applicable for monitoring of compressed air and gases (Nitrogen, Oxygen and Carbon Dioxide) in different production facilities for microbiological, non-viable particulate, oil and moisture content. g. Pharmaceutical gas testing, including testing of nitrogen, oxygen and carbon dioxide, in compliance with international pharmacopeia monographs Commissioning qualification and validation (CQV) of activities of pharmaceutical plants Jan 16, 2025 · Nitrogen is widely used in milling applications within the pharmaceutical industry, predominantly for inerting, product quality and cryogenics. Jan 25, 2025 · Pharmaceutical gases are an integral part of manufacturing, processing, packaging, and quality control in the pharmaceutical industry. The compressed gases nitrogen and compressed air have therefore become the focus of surveillance. Based on this experience, the authorities are focusing now on the quality of pharmaceutical gases. These gases are used in sterile environments, as raw materials, or as process aids to ensure the integrity of drug products. PSA (Pressure Swing Adsorption) Based Nitrogen Plant is to produce Nitrogen gas from Atmospheric compressed air. Jul 9, 2008 · Medicinal gases: pharmaceutical documentation (including recommendation on non-clinical safety requirements for well established medicinal gases) - Scientific guideline Microbial Testing of Compressed Air Micro Testing of Compressed Air or Bioburden Testing per ISO 8573-7 is generally conducted by the pharmaceutical, medical device and food industries. No other changes have been introduced with this revision. Pharmaceutical process air testing with Trace Analytics is easy and straightforward. This validation process must collect In pharmaceutical production environments, the cleanroom user shall guarantee the compressed gas purity to meet or exceed the same cleanroom grade limits. O&G-Grade Nitrogen Gaseous nitrogen with purity levels ranging from 95-99% is useful in the oil and gas industry to reduce the risk of fires and explosions in associated processes. Excess moisture can lead to undesirable chemical reactions, microbial growth, and compromised product integrity. Nitrogen gas reduces the presence of oxygen that may provide the catalyst for combustion or negatively affect product quality. However, like compressed air, Nitrogen gas can become contaminated with various impurities if not properly May 30, 2023 · Explore the vital role of nitrogen in the pharmaceutical industry and its various applications. Its role is indispensable in maintaining the quality, efficacy, and safety of pharmaceutical products, making it a key element in the health sector. 4. This part of ISO 8573 provides general information about contaminants in compressed air systems as well as links to the other parts of ISO 8573, either for the measurement of compressed Leveraging Nitrogen Flushing to Prevent Oxidation in Pharmaceutical Products Oxidative degradation is a major stability concern in the development and lifecycle management of pharmaceutical products. Jan 25, 2025 · Pharmaceutical Compressed Air and Gas Systems: An Detailed Overview Compressed air and gas systems play a vital role in pharmaceutical manufacturing, ensuring the delivery of clean, dry, and contaminant-free air and gases for critical processes. Most recently this high quality compressed air is used in generating high purity nitrogen. Key advantages Testing and monitoring of compressed air and other process gases such nitrogen, oxygen, argon and carbon dioxide that come into direct contact with pharmaceutical products is vital to assuring the quality and safety of those products. Scope: This procedure is applicable for microbiological analysis of compressed air and Nitrogen used at factory for manufacturing and testing. Jan 28, 2025 · Methods and Procedures for Determination of Moisture Content in Gases Used in the Pharmaceutical Industry Moisture content in gases used in the pharmaceutical industry is a critical parameter. We have developed an World Health Organization (WHO) Health Products Policy and Standards Department (formerly Essential Medicines and Health Products) and other departments involved in the supply of oxygen and the inspection of production sites of medicinal gases, raised the urgency for the preparation of the WHO good manufacturing practices for medicinal gases guidance text. A regular Micro Testing program can provide insight to a potential problem long n the pharmaceutical sector. These systems are integral to production, packaging, and quality control, as they influence product safety and compliance with regulatory standards Find out how nitrogen gas improves quality in pharmaceutical product packaging, area blanketing and laboratory processes. While nitrogen and oxygen exist in stable concentrations, the concentration of water vapor is highly variable and must be measured to be determined. Procedure: 4. Compressed air, oxygen, nitrogen and carbon dioxide are often used in pharmaceutical production environments and are subject to the Good Manufacturing Practices. May 3, 2017 · In many cases, gaseous media used such as compressed air contact the product and are thus, by definition, quality relevant, and in particular, of course, in the case of sterile products. This article will explore the importance of nitrogen plants in pharmaceuticals and how they function to ensure the safety and efficacy of pharmaceutical products. Apr 17, 2024 · 1. We have developed an Apr 17, 2024 · Standard operating procedure to check the viable count of compressed air and Nitrogen gas used in formulation of parenterals. The fluids used for the production (water, clean steam and vapor of gas) are a potential source of prod-uct contamination and cross-contamination from one room to another. 1 Take pre-incubated SCD broth tubes from the incubator. Regular quality control testing plays an important role in the safety of your products. In fact, pharmaceutical companies need reliable sources of high-purity nitrogen and can benefit from generating their own nitrogen internally to reduce costs while controlling quality and improving efficiency. Mar 27, 2023 · Nitrogen purity testing is important in the pharmaceutical industry for several reasons. These include INTRODUCTION: Nitrogen gas plays a significant role in the pharmaceutical industry, with a broad range of applications such as transfer, purging, blanketing, drug manufacturing, aseptic packaging, analytical testing, filtration, separation and purification [7]. Nitrogen is commonly used in the pharmaceutical industry for various purposes, such as in the manufacturing process, storage, and transportation of pharmaceutical products. Explore the benefits and applications of nitrogen generating systems in the pharmaceutical industry. It is widely used in different manufacturing and storage processes due to its inert nature, which prevents oxidation and contamination. Nitrogen blanketing reduces the presence of oxygen by replacing it with nitrogen. With this, tanks, pipelines, hoses, vessels, and other process equipment can be 2. Nov 15, 2024 · In the pharmaceutical industry, nitrogen gas is used to replace a hazardous or undesirable atmosphere with an inert dry atmosphere. How the Pharmaceutical Industry Uses Nitrogen Gas Examples of nitrogen gas used in pharmaceutical manufacturing processes include: Blanketing. Oct 16, 2018 · 1. However, compared to e. The objective is to ensure control over viable counts in these gases used in formulation areas. OXYMAT’s lab nitrogen generators provide a reliable, high-purity nitrogen supply designed for the strict demands of pharmaceutical production. In the pharmaceutical industry, nitrogen is essential for maintaining the safety and effectiveness of medications. The quality of the pharmaceutical water (purified water or water for injection) is mastered for many years by the pharmaceutical industry and undergoes specific qualification and monitoring plans. . Jun 1, 2024 · Compressed gases are used at various steps of the pharmaceutical manufacturing process. Sep 22, 2020 · In this Sop, we will explain about Qualification Of Compressed Air And Nitrogen Gas in the Pharmaceutical Industry. To provide a general methodology to be followed for Microbial analysis of Compressed Air and Nitrogen Gas in Quality control, Cephalosporine production block and microbiology laboratory of pharmaceutical industry. These systems enhance product stability, safety, and cost-effectiveness, supporting a range of applications, including lab nitrogen generators for analytical and production purposes.