Public procurement notice: Voluntary Ex Ante Transparency Notice
Published: 2016-04-26
Buyer: Oslo Universitetssykehus HF [Oslo University Hospital]
Country: NO
Region: NORGE
Contract type: Supplies
Procedure: Contract award without prior publication
CPV classification: 33100000
Estimated value: 1 

Technical requirements: The ex vivo cell laboratory produces cells for both treating patients and clinical testing. The ex vivo cell laboratory is certified in accordance with the cell regulations to handle human cartilage cells, bone marrow cells, bladder cells and erythrocytes for use in humans. The manufacturing of cell products is done in accordance with:
— FOR-2015-12-07-1430 Regulations on the quality and safety requirements for handling human cells and tissue (regulations on handling human cells and tissue) and certified by the Norwegian Medicines Agency.
The clean room laboratories are validated in accordance with EU-GMP requirements before they are used. There are stricter requirements in class B clean room regarding low particle numbers in the air, therefore consistency must be documented between the set requirements and the actual conditions. Furthermore documentation must be presented that accounts for the measuring methods that are used and the measurement results.
Efforts are made to have as little dust as possible on all equipment, therefore it is desirable to have the dust level presented if such data exists. It is also desirable that any consumables are stated with their price and replacement frequency.
The equipment, including assembly parts and accessories that shall be placed in the room, shall be made of certified materials and have a hygenic design.
The surfaces shall tolerate cleaning agents that are used in the clean room, for example, acids, alcohol, Virkon, surfactants. Examples of cleaning agents are 70 % disinfection spirit and Klercide Biguanide, Chlorine Quat and Peroxide.
Equipment that shall go into the laboratory must be disinfected. All surfaces shall be cleaned and desinfected with 70 % disinfection spirit. Tenderers must follow the following procedures: Clothing for work in the ex vivo cell laboratory (Doc-id: 2588), as well as Hygiene rules for access to the production premises at the ex vivo cell laboratory (Doc-id: 24930).
CO2 incubator for growing human cells with an option to regulate the CO2 level and temperature. Automatic decontamination. Smooth surfaces for easy cleaning.
The temperature and CO2 level shall be continually logged. Sensors for this are provided by Brookhaven/Houm Facility monitoring system, FMS. The CO2 incubators must be prepared for signal cables for these sensors. The implementation of signal cables must be facilitated. The supplier of the CO2 incubator will decide where the hole for the cable is located, any extra costs involved in this must be stated. Inside the CO2 incubator the temperature sensor must be placed in the incubator's warmest position and the CO2 sensor where there is the highest value.
The CO2 incubators shall be placed in a room that shall fulfil the clean room class B requirements and they must be suitable for placement and use in such rooms. Documentation with testing shall be presented.
The maximum levels apply in total for the entire room, it is therefore important that the equipment that shall be placed in the clean room does not emit particles in practice. In addition it is important to maintain the microbiological burden on the clean room. This means that only CO2 incubators without an open water jacket, but with a separate water reservoir can be used. This is to prevent particle formation and to minimize microbiological blossoming.
Heraeus Cytoperm 2 and Heraeus BBD 6220 were chosen as incubators when the ex vivo cell laboratory started. The Cytoperm and BBD incubators were not certified for a clean room as a starting point and they did not have documentation for use in class B, but they were sold as the best and the newest on the market. After they were installed in 2000, testing showed large particle emissions during normal loads and during decontamination from the incubators, which led to further delays and improvements. The incubators had to be insulated and specially adapted with separate capsules with a fan and HEPA filter in order to reduce the particle concentration in the room sufficiently.
In addition the incubators did not manage to maintain their own specifications on temperature and recovery. Heraeus Cytoperm 2 and Heraeus BBD still do not have documentation for use in class B rooms and the equivalent technical specifications are as they were stated when they were purchased in 2000.
Thermo Forma Steri-cult 3308 fulfils the requirements for a separate water reservoir. It has documentation for operation in EU-GMP class B clean rooms, with the requirements for particle concentration given above. It adds humidity by an ultrasound humidifier via an external water reservoir. The water reservoir can be easily disassembled and cleaned.
The incubator is sealed so that particles shall not leak out into the environment and the growth chamber maintains the class B requirements (ISO EN 14644-1 ISO class 5) via a HEPA filter. In tests it has shown to carry out decontamination as promised with regards to the stated particle concentration and temperature development.