Brazilian vaccine plant case study demonstrates EnviroWater Group’s expertise in sustainable ultrapure pharmaceutical water

Water is one of the primary raw materials used in the development and production of medications and its sustainable and efficient use has become a key topic for pharmaceutical industry, increasing demand for genuinely eco-friendly plant solutions.

EnviroWater Group’s credentials as a reliable partner in this task are showcased in a recent flagship project for a Brazilian vaccine manufacturer that offers an end-to-end solution.

Need for ultrapure water

“Water is a particularly challenging topic in the pharmaceutical industry, as patient safety is paramount,” says Elmar Billenkamp, department manager at EnviroChemie, adding that pharmaceutical and environmental specifications also have to be adhered to reliably.

“Throughout the production process we have ultrapure water that needs to be provided at a consistent quality, as well as process water and wastewater, which has to be treated thoroughly,” comments Billenkamp.

A wealth of expertise in pharmaceutical water

Companies in the expert network of the EnviroWater Group have gained experience in numerous projects for the pharmaceutical industry over the years. The group member companies EnviroFALK PharmaWaterSystems, EnviroDTS and EnviroChemie are all long-standing specialists in the pharmaceutical market and contribute their specific competencies and work hand in hand on joint group projects.

EnviroFALK PharmaWaterSystems provides solutions for generating pure and ultrapure water as well as water for injections (WFI) and ultrapure steam for applications in pharmaceutics, biotechnology and life sciences; EnviroDTS specialises in wastewater sterilisation and decontamination for laboratories, institutes, hospitals and industry; while EnviroChemie develops customized plant solutions for treating cooling water and wastewater and for water recycling for companies in the pharmaceutical industry and life sciences sector.

Innovations for the pharmaceutical industry

This integrations means EnviroWater can provide pharma companies with complete end-to-end solutions encompassing everything from the drinking water inlet, through the generation of ultrapure water and water for injection purposes, all the way up to wastewater treatment from a single source. Joint research and development projects are also in planning.

EnviroFALK PharmaWaterSystems Sales Director Fabian Stapper says one of the benefits of this synergy is better co-ordination with a a single point of contact for all disciplines.

“A general project manager coordinates all activities, this is an added plus that we as a Group can offer our customers,” says Mr. Stapper.

The fact that one person at the EnviroWater Group holds the reins also makes project management easier. “In case of problems or delays, we use our short paths and solve issues internally,” states Stapper. “This means we can work efficiently and profitably. In turn, the customer can rely on our adherence to deadlines, saving time, money and stress.”

Solution concept for vaccine production in Brazil

One example of this concept can be found in Brazil, where a vaccine manufacturer is planning a new, large-scale pharmaceutical production facility in Rio de Janeiro to produce vaccines against yellow fever and COVID-19. Three buildings are planned, each with its own focus. The production processes are very complex and pose high requirements for the water technology.

The EnviroWater Group is contributing to the project with a modular solution concept for water treatment along the entire process: all three buildings will require different ultrapure media for production and has to be developed by EnviroFALK PharmaWaterSystems. Engineers and technicians from EnviroDTS will thermally inactivate the resulting wastewater before it progresses to the final step of the process, while the wastewater treatment plant is being engineered by EnviroChemie.

Production of ultrapure media

Numerous individual subprocesses are involved. To produce its vaccine, the company requires three different media qualities in each of the three buildings: starting with purified water (PW) that provides a source for water for injection purposes (WFI) and ultrapure steam.

PW is demineralised from feed water with all salts removed using various processes. The most important methods are filtration, softening, reverse osmosis and electro-deionisation. Because the production of purified water is subject to strict regulations, it is vital that the microbiological quality of the feed water remains constant.

Regional factors

However, feed water quality varies in regions such as Brazil, due in part to natural events such as heavy rainfall during the wet season. Therefore, water quality must be analyzed particularly frequently and precisely.

“This requires experience and regional expertise,” explains Stapper. “The right selection of process technology plays a significant role in the reliable functioning of the systems.”

In the plant in Rio de Janeiro, five PW generators from EnviroFALK PharmaWaterSystems with a total output of about 18 cubic metres per hour (m³/h) are required to ensure that production is supplied with sufficient purified water.

Of this, about 13 cubic metres of water per hour is distilled for injection purposes in a total of four generators, which then needs to be stored safely and distributed. This very pure water is subject to the very highest international standards in pharmacopoeias and requires particular care to ensue absolute purity.

Similar standards apply for ultrapure steam, which is used for sterilisation at over 121°C. Here, five UPS generators with a total capacity of about eight tonnes per hour (t/h) ensure a sufficient quantity.

The EnviroWater Group design concept includes a high degree of redundancy across the total generation scheme to ensure uninterrupted supply of ultrapure media at all times.

Thermal inactivation

Wastewater from medical production generally needs to be thermally inactivated due to strict hygiene regulations. In the project in Brazil, each building produces about ten cubic metres of wastewater every hour. Here, it is important to guarantee a temperature of 135°C and a retention time of at least two minutes in order to kill all microorganisms and inactivate viruses.

EnviroDTS therefore plans to equip each building with a Sterifix E10200 continuous flow system, which continuously processes the generated wastewater. “Heat exchangers ensure efficiency here, thus lowering operating costs,” explains Billenkamp. An integrated CIP system cleans the exchanger and the retention stage on a cyclical basis.

Wastewater treatment

According to the plan, about 380 cubic meters of organically contaminated sanitary wastewater and around 440 cubic meters of industrial wastewater will be generated every day across the entire site, requiring to be collected in a mixing and expansion tank and continuously fed to the wastewater treatment plant.

The treatment concept by EnviroChemie proposes a membrane-biological Biomar OMB process with nitrification, denitrification and downstream reverse osmosis. The permeate resulting from the reverse osmosis is to be sterilised via a UV system so that it can be utilised again in production.

“The entire plant is designed in such a way that the concentrate from the reverse osmosis complies with the discharge values,” explains Billenkamp. This applies in particular for the COD limit value of 150 milligrams per litre.

Water experts on site

Some of these large wastewater treatment systems are built in Germany and tested before being shipped, while others are constructed locally.

“We also have local representatives and work with the engineers on site,” says Stapper.

He adds that it is especially important to know the regulations, which differ from one region to the next, and to always remain up to date with them: “To this end, we stay in contact with local authorities and take care of planning applications and permits.”

The case study demonstrates that degree to which treatment of water and wastewater in the pharmaceutical and life sciences industry is demanding and location-specific. If a pharmaceutical company decides to entrust a single source with the planning, construction, commissioning and outsourcing of the operation of its entire water and wastewater management, it enjoys a multitude of benefits, especially with a holistic concept that helps the client use resources more efficiently and work sustainably throughout the entire process and save on operating costs through plant optimisation measures.

“Ideally, we are involved in the new construction of plants right from the beginning,” says Billenkamp. “The planners know the customer’s range of services and we contribute our water expertise.”

Resources

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