Rushan Jinguo Food Co., Ltd , https://www.jinguofood.cn
Hydrogen peroxide vapor disinfection pharmaceutical aseptic filling room (RBDS room biological purification case study)
RBDS case study
- Hydrogen peroxide vapor disinfection pharmaceutical aseptic filling room
A well-known multinational pharmaceutical company in Madrid, Spain
challenge
A pharmaceutical production facility requires Bioquell's Room Bio-Clean Service (RBDS) to remove Staphylococcus epidermidis contamination from its aseptic filling plant (approximately 1000 m 3 ). The target area consists of a Class A sterile zone of approximately 300 m 3 and a Class D clean zone of 700 m 3 according to the European GMP classification criteria. The main criteria for selecting a disinfection method are:
1) Prove effective killing of Staphylococcus epidermidis;
2) Ability to comply with FDA regulatory requirements;
3) In-situ fumigation to disinfect complex filling, capping, washing and lyophilizing equipment;
4) No residue technology to ensure that there are no toxic residual products;
5) Minimize downtime; and
6) Provide verification documents for the bioavailability of the sterilization process.
Program
Bioquell's RBDS was selected as the only solution that met all of the above requirements. The aseptic zone and the clean zone are separately fumigated. In order to ensure the effective diffusion of steam, six Clarus R-type hydrogen peroxide vapor (HPV) generators were selected, and eight Clarus R2 ventilators were used to remove excess HPV at the end of the cycle and placed one in each zone. The test equipment monitors key parameters in real time.
Each zone is sealed prior to the start of fumigation and is maintained until the end of the HPV decomposition of the catalyst into water and oxygen (the building air handling system AHU can also be used to accelerate this process). The entire process is monitored and controlled by a control computer outside the room, and a hand-held HPV sensor is used to monitor the leak around the area.
Gas biological purification cycle verification
Small stainless steel sheets sealed in "Tyvek" contain Bacillus stearothermophilus dry spores as biological indicator BIs to detect the effectiveness of fumigation. Two different spore numbers were used: a standard test point using a spore count of >1.0x10 6 and a challenge point using a spore count of >1.0x10 4 .
Standard BIs were distributed in the facility according to Bioquell's protocol method. The location of the challenge BI before the start of fumigation in each area was also determined. In addition, the target area was also placed with metal plate inoculated S. epidermidis.
result
The B. stearothermophilus indicator was recovered after completion of the ventilation phase and cultured for 7 days at 60 degrees Celsius. A positive control without fumigation will show signs of microbial growth. All BIs at 72/72 standard sites and 15/15 challenge sites were completely killed, showing no microbial growth. BI challenge sites include: filling, capping, cleaning and lyophilizers, AHU internal piping and a transfer compartment interior. 37/37 auxiliary S. epidermidis indicators were also killed.
Devices exposed to HPV were unaffected and showed good material compatibility for the RBDS process.
in conclusion
At the standard site 6-log kill rate, the challenge site 4-log kill rate (Bacillus stearothermophilus BI packaged in "Tyvek" material) bio-purification target is achieved throughout the facility, the entire fumigation process is It was completed within three working days. The RBDS system provides a very fast and efficient fumigation system that combines rapid ventilation to produce minimal cycle times.
This system can be used in a wide range of other applications such as the elimination of specific microorganisms, routine fumigation in laboratories, including biosafety facilities, clean rooms, pharmaceutical manufacturing plants and hospitals. The RBDS system can be expanded infinitely for fast and efficient biological purification of very large spaces and entire buildings.
For more details on HPV bio-purification solutions including equipment and room service, please contact Bioquell China.