BioCapt SU
8Pages

Reducing the Risk to Product and the Environment During Sampling Without measurement there is no control

Problem False Positive Results and Batch Loss Personnel pose the greatest risk of false positives in aseptic processing. Investigations are required when microbial activity is detected, costing up to $18,000 USD per investigation and the risk of batch loss.1 Fully Exposed Media Direct Operator Contact Sterilization Cost and Risks Autoclaving and disinfection are costly and timeconsuming processes used for traditional air sampler sterilization. Additionally, handling and transfer from the autoclave may reintroduce contamination. Contamination Risk for the Final Product Regulations state that...

Solution BioCapt® Single-Use Microbial Impactor The BioCapt® Single-Use Microbial Impactor eliminates the risk of false positive results and final product contamination from microbial sampling interactions, while decreasing the cost of investigations. The single use sampling head enables manufacturers to monitor their full process, eliminating the risk of non-conclusive results by settle plates. The innovative design is a combination of media plate and sampling head into a single unit. This unique solution eliminates the handling risk, costs, and complications related to autoclaving and...

Double-Bagged, VHP-Impermeable BCSU follows a triple-wrapped packaging concept where the internal 2 bags consist of a VHP impermeable film. Extended Storage and Shelf-Life The BioCapt Single-Use (BCSU) can be stored from 2 °C to 25 °C. This allows storage at room temperature and frees up valuable refrigeration space. The media are validated for 9 or 12 months shelf life based on the formula. Stable Transfer with Stackable Plates The plates, exterior casing allows the units to be securely stacked, reducing the risk of accidental media exposure during transfer to the lab. Media has less risk...

TO IMPLEMENT Seamless Integration with Existing Systems BioCapt Single-Use can easily replace any existing microbial sampling head, whether attached to a mobile instrument or installed in a remote location. Mobile Sampling — Grades A, B, C, D Remote Sampling — Grades A, B Remote Installation Accessories Multiple mounting accessories allow connection to new or existing environmental monitoring systems. BioCapt Single-Use can be connected to vacuum tubing that is in a vertical or horizontal orientation. Horizontal Connection Vertical Connection

Viable Air Sampler with Integrated Media The innovative design of the media plates and sampling head eliminates operator-induced contamination, as well as handling and sterilization costs associated with traditional samplers. High Collection Efficiency BioCapt Single-Use utilizes the same radial slit inlet pattern as the traditional BioCapt air sampler, thereby maintaining the same biological and physical collection efficiencies. Lightweight and Ergonomic The lightweight, all-in-one design simplifies operator handling and prevents any contact with the agar, even in the event of a fall....

Media Testing Every batch of media is gamma-irradiated and tested for the following attributes. Appearance: Color and hydration Sterility Testing: Incubation to assure no growth for 5 days Effectiveness Verification: Neutralizers, Penicillinase, or Beta-lactamase pH Testing: Trypticase Soy Agar (TSA) range: 7.1 to 7.5 pH Sabouraud Dextrose Agar (SDA) range: 5.4 to 5.8 pH Growth Promotion Testing: TSA media (6) • Staphylococcus aureus • Pseudomonas aeruginosa • Escherichia coli • Bacillus subtilis • Candida albicans • Aspergillus brasiliensis SDA media (2) • Candida albicans • Aspergillus...

1 | Cundell et al., “Novel Concept for Online Water Bioburden Analysis: Key Considerations, Applications, and Business Benefits for Microbiological Risk Reduction,” American Pharmaceutical Review, July 2, 2013. http://www.americanpharmaceuticalreview.com/Featured-Articles/140513. 2 | FDA aseptic Manufacturing guide, EU -GMP Annex 1, ISO 14698 3 | EU GMP Guide, Annex 1 & Guidance for Industry Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice Food and Drug Administration September 2004 Pharmaceutical CGMPs HEADQUARTERS 5475 Airport Blvd Boulder,...