Pharmaceutical

Kenexis expertise in the tools and techniques and pioneering research and development in technical safety engineering has allowed us to become the most trusted resource for helping companies to ensure that their processes are safe.  This is particularly true for technologies and processes where the potential consequences can be underestimated. Pharmaceutical processes typically include multiple reaction steps and unit operations, and also additional operations such as sterilization and milling.  These activities benefit from detailed quantitative analysis of potential causes and consequences.  Kenexis is an efficient, effective, and trusted resource for analyzing the risks involved in the manufacturing process used in the pharmaceutical industry.

Chemicals used in pharmaceutical processing can be very dangerous.  Many reaction steps require reagents that are toxic, flammable, or highly reactive.  Even the Nitrogen, which comprises 78% of the air we breathe, presents a significant risk to life. Not understanding and analyzing the risk thoroughly of any process, including utility activities such as sterilization, can be fatal.

We analyze risks and design appropriate safeguards.  We do this through the application of proven engineering tools and techniques, such as Hazards and Operability Studies (HAZOP), gas dispersion, fire, and explosion modeling studies, design of safety instrumented systems to allow for emergency shutdown or de-inventory, placement and design of gas detection and fire detection systems, and facility siting to ensure equipment and occupied buildings or spaces like control rooms are appropriately separated.  Some of the processes that we have already successfully analyzed and developed safeguarding solutions are listed below.

Some of the pharmaceutical processes that we have already successfully analyzed and developed safeguarding solutions are listed below.

Runaway ReactionsSterilizationMilling

Contact us at info@keneis.com about your challenges so that we can help you ensure your processes are safe and sustainable.

Runaway Reactions

Many of the chemicals used to make pharmaceuticals have are flammable, toxic, or highly reactive chemicals and require risk assessments and engineering controls in addition to personal protective equipment. Runaway reactions occur in process reactors or in the storage of the chemicals.

Risk management begins with performing HAZOP (PHA) on the process units and equipment. Runaway reactions may require automatic emergency actions including dumping, quenching, or inerting. Since the possibility of flammable and potentially toxic materials, detector coverage mapping is often needed to place flammable gas, toxic gas, and fire detectors appropriately in a facility.  Gas dispersion modeling is usually required to determine the environments effect on the gases released to determine appropriate locations for detectors. In many cases, facility siting is essential to keep potential consequences from runaway reactions from impacting occupied buildings and spaces like control rooms.

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Contact us at info@keneis.com about your challenges so that we can help you ensure your processes are safe and sustainable.

Sterilization

Sterilizing involves processes that can present pressure, temperature, and chemical hazards. Hazards including chemicals like ethylene oxide, a toxic and flammable gas, is used in many processes including sterilization. It is possible to create an explosive vapor-air mixture inside of sterilization or storage containers.

Risk management begins with performing at HAZOP (PHA) type of Process Hazards Analysis (PHA) on the process units and equipment. SIS should be used to protect equipment and personnel.  Since the process includes flammable and toxic materials, fire detection coverage mapping is needed to place flammable gas, toxic gas, and fire detectors, especially around high probability leak sources.  Gas dispersion modeling is commonly required to place gas detectors for the flammable and toxic gas and potentially toxic byproducts which can be especially problematic for indoor installations.  Facility siting will be essential to keep potential consequences of process incidents from impacting occupied buildings and spaces like control rooms.

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Contact us at info@keneis.com about your challenges so that we can help you ensure your processes are safe and sustainable.

Milling

In addition to the potential chemical hazards present, milling presents a risk hazard in addition to the chemicals being processed. Milling creates dust which can deflagrate and if contained in space can cause an explosion. The initial explosion can cause a secondary explosion in areas where dust has accumulated. Dust explosions are too common and can be mitigated once the hazard is understood and the safeguards are in place. Unfortunately, even the safeguards can introduce additional risk. In addition to grounding, a common way to safeguard for dust explosions is to remove the oxygen with nitrogen so the fire-triangle is incomplete. Nitrogen can create an asphyxiation hazard not only in enclosed spaces, but near leaks or when equipment is opened.

Risk management begins with performing HAZOP (PHA) on the process units and equipment. Since the process includes flammable and potentially toxic materials, detector coverage mapping is needed to place flammable gas, toxic gas, and fire detectors.  Gas dispersion modeling is required to place gas detectors for the flammable and toxic gas and potential lack of oxygen which can be especially problematic for indoor installations.  Facility siting will be essential to keep potential consequences from incidents from impacting occupied buildings and spaces like control rooms.

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Contact us at info@keneis.com about your challenges so that we can help you ensure your processes are safe and sustainable.