Industrial Gases – Important Chemicals for the Life Sciences Industry
possible onsite generation of nitrogen that meets quality requirements (to the author’s knowledge such a solution is not available for other gases.); micro bulk supply systems for gases such as nitrogen, oxygen, argon, and CO2; and in-line cryogenic filtration systems to ensure that the excipient, such as liquid nitrogen (LIN), is sterilized and is microbe-free. Certain bacteria are known to reside in cryogenic conditions in LIN. Pall Corporation offers full service in supplying sterile filters for drug manufacturers, including services such as maintenance and bio-burden analysis. Meissner Filtration Products offers cryogenic temperature filters but does not provide maintenance and bio-burden analysis on regular basis. Both companies offer services online. Some of the online capabilities include: automatic on time delivery using a telemetry system; on-demand, online data retrieval and invoices; purchase volume/tank reading delivery and account history; the ability to place and check order status; supply monitoring, lead times, and customized stocking levels; single-client extranet; convenient, fast, and efficient transactions and processes; and cost monitoring. The leading industrial gas companies’ distribution teams use their own fleet of drivers who operate under their Quality Management systems. All medical and pharmaceutical products are cleared by an independent quality control unit for each delivery. The drivers have to be specially trained to deliver validated product under the same Quality process. All drivers need to receive at least 20 hours of training to deliver medical and pharmaceutical products and are re-tested every year. They also need to carry a Transportation Workers Identification Card (TWIC) issued by Homeland Security. Strict procedures need to be followed in changing out the supply of gases. These procedures involve pre-installation steps that include a site survey, a process audit, a foundation review, and a coordination meeting. Job Hazard Analysis, a safety review, safety training, documentation, and a communication plan are also included. New tank(s) need to be purged per strict procedures and before bringing them on line. In preparing a portable trailer for a temporary supply, quality of the product needs to be confirmed prior to the connection to the plant line. Once approved by the plant, the connection is made to the main supply line February 2015 – CryoGas International
How Gases are Used in Life Sciences Markets Sector
Gases
Uses
Flammable Solvents Inerting
Nitrogen
Manufacturing pharma products
Gas Safety
Nitrogen
Ensure safe operation when using unsafe products
Oxygen, Nitrogen
Maintaining Dissolved Oxygen levels; stripping organics from the WWT operation
Recovery of VOCs
Liquid Nitrogen (LIN)
Remove organic solvents from the vent lines prior to vent release
Green Cooling Solutions
LIN
Greener solution to mechanical refrigeration
Source controlled gases
Nitrogen, Oxygen, CO2
Various uses
Reactor’s temperature control
LIN
Drug manufacturing
Efficient freeze-drying
Nitrogen
Lyophilization operation
Waste & Water Treatment
Process Efficiency
In-line Blending Technologies
Nitrogen, Oxygen, CO2
Personalized medicines
Gaseous chemical reactants
Oxygen, CO2
Pharma products
Bio-production boosting with O2
Oxygen
Aerobic fermentation operations
Bioreactor feed with O2, CO2 and N2 cryogrinding, micronizing
Nitrogen
Avoid oxidation, maintain product integrity
Cold chain transportation
Nitrogen
Pharma products
Supercritical CO2 supply for product purification and separation
Carbon Dioxide
Various applications
Cryo spray crystallization
LIN
Pharma products
Maintain drug properties with pharmaceutical gases
Nitrogen
To ensure quality of drug products
Traceability of gases
Nitrogen
Point of Use analysis
Compliance and validation for gases from source to Point of Use
Nitrogen, CO2, Oxygen
Determine quality of the excipients
Analytical performance
Nitrogen, CO2, Oxygen
On-site analysis of excipients
Regulatory Compliance
Figure 1
and the switch to a temporary system takes place by switching valves. There are many technologies available that monitor industrial gases and these yield both economic and operational benefits. Technology Services Inc. combines many products and technologies to develop valuable applications and services not only for its customers but also for society. We encourage innovative technologies that curb polluting emissions and lower the industry’s energy use.
Source: Brahmbhatt
Dr. Brahmbhatt is President of Technology Services Inc. (www.TSINC-US.com), based in St. Louis, Missouri. He has a wealth of knowledge in industrial gas applications in the chemicals, pharma, biotechnology, and metal industries and is the inventor of more than 25 patents in these areas. He has more than 35-years experience in the industry including stints at Exxon, Air Products, Messer Griesheim, and Air Liquide. He can be reached at Sudhir.Brahmbhatt@TSInc-US.com. 23