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High concentration fumigation 8000m3 pharmaceutical sterile preparation facility within 24 hours - RBDS room biological purification case
RBDS case study
- High concentration fumigation 8000m 3 pharmaceutical sterile preparation facility within 24 hours
A well-known multinational pharmaceutical company in Belgium
challenge
A well-known multinational pharmaceutical company whose production facilities in Europe require two routine sterilizations per year. Because each stoppage brings a loss of revenue, the customer requires a fast and reliable biological purification program.
Program
The customer has signed an annual room disinfection service (RBDS) agreement with Bioquell for the next five years. In order to minimize downtime and related financial issues, two separate product lines will simultaneously perform high concentration fumigation. Once routine maintenance of the production facility is completed, Bioquell will fumigation of the facility on a contract basis to allow the facility to be re-introduced. The total construction volume of the two growth lines is approximately 8000 m 3 and exceeds 60 rooms. Because of the good material compatibility of hydrogen peroxide vapor (HPV), all equipment in the room remains in the facility to undergo in situ bioremediation.
In order to reduce the downtime, Bioquell deployed a large team to complete the biological purification work within 24 hours, and reached the natural state without residue to instantly restore the facility. The previous disinfection method required more than 60 hours of fumigation, and the more difficult task was to consume Timely and laborious to remove toxic residues.
Bioquell deployed a total of 40 Clarus R-type generators and several engineers, each of whom was trained in equipment operations and health and safety procedures.
In addition to the regular service once every six months, the customer signed a quick response booking service with Bioquell in the event of a sudden pollution accident. In August 2005, Bioqeull received a confirmation notice from the UK headquarters within 48 hours. The service team was dispatched and the fumigation of this large facility was completed within 24 hours.
Gas biological purification cycle verification
Such facilities are used to produce intravenous drugs and must achieve the highest level of sterilization, and the entire process is validated using commercial biological indicators (BIs). Bacillus stearothermophilus spores were used as biological indicators (BIs) to fill the entire facility and exposed to the disinfection cycle. After the cycle was completed, BIs were immediately transferred to soybean broth (TSB) and cultured at 60 degrees Celsius. . The accredited agreement states that BIs should be cultured for 7 days. However, the characteristics of this microorganism can be observed within 24 hours. This preliminary result can give a very clear final expected result, and the user can judge whether to resume production. Users can also use the culture dish and contact pads to verify this sterilization process.
result
Bioquell's RBDS has served the facility more than six times and has achieved the full kill of BIs in every service.
in conclusion
The complete killing of Bacillus stearothermophilus spores is achieved in each of the two target facilities, and RBDS provides a fast and efficient fumigation service that combines the latest and unique rapid ventilation methods to produce minimal cycle times throughout The cycle time includes equipment placement and recycling in less than 24 hours. This fumigation cycle has now been validated through three iterations of deployment, and users can now re-start production immediately after completing the cycle.
RBDS is a fast and very flexible service that can be used to fume steaming equipment from ambulances to any sealed space such as the entire building. The system is fully controlled by professional engineers through an external computer and dedicated control software.
Engineers use sensors placed in the area to feed back online data in real time to ensure micro-condensation is formed throughout the target area (ie, rapid bio-purification stage), and use bio-indicators for verification at each cycle, providing one for both fast and efficient Unbeatable fumigation solution.