Hot Air Sterilisers for Cleanroom Classes ISO 5 and ISO 7 acc. DIN EN ISO 14644-1

Today, the demand for reliable, fast and energy-efficient heat treatments is greater than ever in the automotive and aerospace industries, the electronics and bio-pharmaceutical industries as well as in university research laboratories.

Our vacuum drying ovens are tried and tested solutions for drying temperature-sensitive products and removing residual moisture from capillary tubes. In vacuum drying, a vacuum is built up in the usable space and the product is heated accordingly. According to the vapour pressure--temperature curve, this also reduces the boiling point of liquid mixtures (water and solvents) which evaporate at significantly lower temperatures. Dehumidification and drying processes under vacuum are particularly gentle on the product and also reach difficult-to-access places within product geometries. In addition, air and vapour trapped in the product are reliably removed, and re-condensation is avoided.

WIBObarrier. Reliable protection for employees, products, and the environment. The WIBObarrier was specially developed as a sitting or standing workstation for areas where stable personal and product protection and high clean air quality are required. Depending on the application requirements, the WIBObarrier can be designed as an open or closed system and configured to a wide range of customer specifications. Benefit from first-class quality and adaptability.

WIBOsafe aseptic isolators offer safe product protection when processing sensitive materials and during aseptic production. The targeted air flow creates a defined positive pressure that prevents the ingress of particles in the event of leakage and thus protects the products from contamination. Depending on requirements and work processes, the isolator can be designed modularly and ergonomically with one or more isolator chambers and material locks. 

Personnel airlock with active cleaning. Safe entry into the cleanroom. The active airlock works according to the principle of rotational cleaning. The individual stands centrally under the high-performance nozzle rotor and is cleaned from all sides. The perfect combination of small air nozzles with a high pressure ratio and a 450-fold air exchange rate ensures highly effective cleaning of particles on cleanroom clothing. Alternatively, the active airlock can also be equipped with static nozzle strips in the corners. The turbulent cross-flow ensures optimal cleaning.

Weiss Technik’s WIBObarrier® system was designed especially for working areas in which it is necessary to protect persons in a stable manner and maintain a high clean air quality. Our innovative laboratory safety workstations operate in accordance with the three-zone principle. The outlet nozzle integrated in the anterior hood region forms a stable clean air curtain, which protects employees, products and ambient surroundings.

WIBOsafe containment isolator for personal protection The WIBOsafe containment isolator ensures maximum personal, product, and room protection when handling highly active substances. The containment isolator was specially developed for activities such as weighing, transfer, and sampling according to the highest safety standards. The closed front window creates an enclosed atmosphere that shields the work area from the surrounding area. To increase operator protection, the system is operated under negative pressure in order to prevent leaks to the outside.

Laminar flow product protection hoods and cabins model MVF/FFM/RK Our BDK laminar flow product protection hoods and walk-in cleanroom cabins type MVF/FFM/RK offer a high level of protection against contamination and can be combined with systems of almost any size. They are used wherever cleanroom conditions are required, for example for the superstructure of production lines, machines, laser systems, filling stations or packaging systems for the pharmaceutical, food and cosmetics sectors. They are manufactured in compliance with GMP and FDA regulations and achieve ISO cleanroom class 5 to 8 in accordance with ISO 14644-1, depending on their intended use.

A climatic walk-in chamber helps you to simulate seasonal differences and different climatic zones when setting up test conditions for your products and components. Your products must be able to withstand a variety of temperatures during manufacturing, transport, storage and use. The Weiss Technik Walk-in Chamber ClimeEvent will help you to test the influence of temperature and humidity on the properties, function and lifespan of your products.

Safety workbenches for cytostatics according to DIN 12980 in custom designs The BDK-SV/UVF-SV safety workbenches for cytostatics, designed in accordance with DIN 12980, guarantee maximum personnel, product and cross-contamination protection thanks to the 3-filter system. They are used for work with so-called CMR substances in pharmacies and clinics as well as in the pharmaceutical industry and are also used in S3 and S4 or BSL 3 and 4 (biosafety level) laboratories. The cytostatic workbenches achieve ISO 14644-1 Clean Room Class 5 or EU GMP Class A in the work area.

WIBOclean personnel decontamination airlock with spray shower. All-round cleaning of personnel in full protective suits. Handling highly toxic substances in secure chemical and pharmaceutical laboratories requires the highest standards of quality and safety. The decontamination airlock was specially developed for cleaning personnel in full protective suits and offers a safe and GMP-compliant solution for removal from contaminated areas.

Hot Air Sterilisers for Cleanroom Classes ISO 5 and ISO 7 acc. DIN EN ISO 14644-1 If you want to quickly, safely and cost-effectively sterilise samples or products, then the process of dry heat serialisation is an interesting alternative to the other existing procedures. Only hot air is used in this procedure. The sterilisation at high temperatures makes the use of chemicals from other procedures redundant.

With the PharmaEvent mobile stability test containers, you not only gain flexibility but also remain consistently uncompromising. The comprehensive GMP-compliant basic equipment is the ideal basis for high-precision stability tests, and the wide range of options allow you to customize the equipment to your specific needs.

The housings can be made of either powder-coated sheet steel or stainless steel. The low-vibration radial fan and glare-free LED lighting ensure a comfortable working environment. The work area can be enclosed at the sides with retractable acrylic, polycarbonate, or safety glass panels. Hinged or sliding windows are possible at the front. The workbench is equipped with pre-filters and H14 HEPA filters. The differential pressure of the filters and the flow in the work area are constantly monitored. Optional equipment includes UV sterilization lamps with timers, sockets, data sockets, media connections (gas, water, vacuum, nitrogen) and cable glands. Additional options are available on request.

GMP- and FDA-compliant lifting devices: highest standards for pharmaceutical systems The GMP- and FDA-compliant lifting columns and lifting and tilting rotating devices are designed to fit the clean air workstations of Weiss Pharmatechnik and can be integrated into existing clean room concepts. Work such as transferring, filling, and weighing can be carried out safely while maintaining the protective systems. The lifting devices are made entirely of stainless steel and are thus easy to clean. They offer maximum process reliability when lifting, tilting, and rotating.

Glove testing devices for isolators and barrier systems - maximum safety for your processes Glove ports in isolators, RABS and barrier systems must be regularly tested for leaks in accordance with GMP Annex 1. This is the only way to guarantee the sterility of the systems. The glove testing device from Weiss Pharmatechnik offers reliable in-situ testing. It is fully automated and enables fast and uncomplicated glove tests in accordance with cGMP.

The walk-in open safety workstation protects employees and the room during work such as filling and transferring, weighing, loading and unloading, and the sanding, spraying, and painting of workpieces as well as when enclosing machines. Released product dusts or gases are reliably captured with the help of targeted air flows from ejector nozzles and fed into the extraction system. The WIBOjekt free workstation has a robust retention capacity based on ISO 14175-3.

The energy-efficient class II safety workbenches protect people and the surrounding area from harmful emissions and protect products from contamination. They offer TÜV-tested and certified safety according to DIN EN 12469 and meet the requirements of clean room class 5 according to DIN EN ISO 14644-1 or class A according to EU-GMP guidelines in the work area. In addition, they meet safety levels S1 and S2 and/or Biosafety Level (BSL) 1 and 2.

Consistent compliance with stability tests Medicinal products are subject to particularly strict guidelines in order to ensure patient safety and efficacy. With our stability testing systems, you can determine the conditions under which pharmaceutical substances have the longest shelf life in accordance with compliance regulations. The spectrum ranges from laboratory-scale systems to walk-in climate chambers for optimum long-term testing. The functionality of all systems is based on a risk-based approach and with all the necessary device functions for ideal GMP compliance.

The WIBOjekt® biosafety cabinets contain ejector nozzles that are coupled with stabilisers to ensure a safe clean air curtain, which shields the working area from the surrounding area in a targeted manner. The air which flows through the outlets captures pollutants such as airborne product particles or gases and guides these to the suctioning device. By doing this, the WIBOjekt® air flow control principle guarantees optimal protection of persons and areas.

The WIBOjekt workbench is a robust industrial workstation for personal and environmental protection. It offers flexible application options for working with harmful substances and is both ATEX- and GMP-compliant. The WIBOjekt system is suitable for activities such as transferring and filling, weighing, cleaning, cutting, assembling, and soldering as well as for general laboratory activities.

Consistently uncompromising in stability tests in almost unlimited chamber sizes Medicinal products are subject to particularly strict guidelines worldwide. With our stability testing systems, you can determine the shelf life of pharmaceutical substances extremely safely and in accordance with legal requirements. The spectrum ranges from laboratory-scale systems to walk-in climate chambers for optimum long-term testing. All systems have the necessary documentation options according to FDA 21 CFR Part 11 and EU GMP Annex 11 and comply with ICH guidelines Q1A and Q1B.

The Pharma cabinets from weisstechnik® were specifically developed to meet the requirements of a test laboratory in pharmaceutics. They are robustly constructed and available in four sizes: Pharma 280, Pharma 600, Pharma 1300 and Pharma 2000.