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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

CryoGas February 2015 Vol. 53, No. 02  
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