Reliably minimise risk
Produce and store
Ask the expert: Miroslav Horvat
Managing Director of Sales and Service at Weiss Pharmatechnik GmbH
What’s new in the world of pharmaceutical engineering?
Last year we moved from Hude to Oldenburg and our production facilities and offices now span over 8,000 m², which is a 120% increase. We used the move as a chance to make the building future-proof so that it is optimised for our processes, from the air ventilation to each workstation. In that way we can significantly increase our efficiency and therefore further improve our competitiveness.
How are you further developing your product portfolio?
In the course of optimising our processes, we have also streamlined our product portfolio and made it even more customer-focussed. A strategically important area of the business is isolators to protect people, processes and products. This is a notable, sustainable market and it is the perfect opportunity to systematically continue developing our existing product range. We understand the industry and its needs, so we can apply the necessary expertise to get off to a flying start in this market.
What goals are you pursuing with the isolators?
With the rapid development of personalised medicine and gene therapy, there is also an increasing need for safe and secure production and processing solutions. Highly sensitive pharmaceutical products must be reliable and reproducible at a consistent quality, as independent as possible of the appointed personnel. We already offer our clients GMP and FDA regulated compact solutions and we will further increase our portfolio in this field.
Secure pharmaceutical production
weisstechnik® protects people, processes and products
The pharmaceutical industry works with sensitive and dangerous powder and liquid substances and products. Whilst these must be protected from contamination and external influences, the people who work with these must also be protected from their harmful effects. Weiss Pharmatechnik develops and implements tested and financially viable solutions in the following fields: containment, stability testing and heat engineering and also offer comprehensive services including replacement part management to maintain operational safety.
Needs-based high containment
Isolators, safety workplace systems and sluice systems for a protected atmosphere
Weiss Pharmatechnik offers a wide range of containment solutions. Examples of these are the WIBObarrier® safety workplace system and the WIBO® sluice system, as well as isolator technology. These ensure a protected atmosphere in the smallest possible area and replaces increasingly cost intensive, classic cleanrooms. The isolators are customer-focussed in design and production. They are designed, for example, as vacuum solutions to protect people and the environment, or as pressurised systems to protect the product.
Reliable stability testing
Environmental simulation for pharmaceutical products
suitable storage options are required in order to conduct and document GMP and FDA compliant stability testing of the storage of active substances and medication- Weiss Pharmatechnik supports its customers with certified standard solutions and individually designed special solutions from the PharmaEvent series. The wide variety of products range from compact stability test chambers for laboratory use, to walk in stability test chambers, or those which are accessible using a fork lift truck.
Control and documentation software
The control and documentation software, SIMPATI Pharma, makes it possible to efficiently monitor the facility and the systems. For example, there are records of warning and alarm signals and all user interaction (Audit Trail) as well as tamper proof data storage. Furthermore, there is the option of validation documentation which is compliant with GAMP. Naturally everything meets the requirements of FDA Guideline 21 CFR Part 11 and EU GMP Annex 11.
Heat engineered sterilisation
For cleanroom classes ISO 5 and ISO 7 (DIN EN ISO 14644-1)
The weisstechnik® SteriEvent series offers particularly quick and cost-effective solutions to sterilise pharmaceutical products. The hot air sterilisers use the dry heat process to sterilise and pyrogenise products at temperatures of up to 350 °C. This reliably meets all current GMP and FDA guidelines and can be adapted to customer requirements. Examples of this are open hatch solutions or process visualisation solutions.
Service and spare part management
Enjoy maximum operational security
As a long-term partner of leading pharmaceutical companies, weisstechnik® offers industry optimised and coordinated solutions. These begin with professional equipment design and production, including certification. Modifications are then carried out to the equipment to save energy or requalify them as required. During operation, there is a guaranteed fast and professional on-site service 24 hours a day, 365 days a year. This can be further optimised on-site with risk-based spare part logistics. Stay up-to-date by registering for our newsletter.