Steam Sterilization is the most crucial aspect of any healthcare industry due to its wide spectrum of possibilities especially claiming your system as sterile or non-sterile. Steam-Thru connections were developed and implemented as a proper control over sterilization path for better isolation between non-sterile and sterile paths. Do you come across the hurdles in claiming sterility for the healthcare products? To justify this, industries follow validation activities creating exhaustive documentation and cumbersome maintenance.
During the validation activities, technical hurdles and deviations are bound to happen regarding sterility assurance. Hence, to avoid these concerns, a Steam-Thru connection (mechanical component) may replace the traditional setup and help in avoiding unnecessary documentation hassles and undesired regulatory invitations.
Steam-Thru Connection allows the steam to pass directly through the lower ports and then to the equipment. After the SIP (Sterilization In-Place) cycle gets complete, the connector’s valve then actuates, creating a sterile flow path to single-use systems. Then, media safely transfers without the cleaning and validation concerns associated with reusable components.
The new Steam-Thru II from Colder Products Company built upon this proven technology, which offers the flexibility of “steam on” and “steam off” functionality. Also, an innovative design allows the valve to return to the steam position, enabling a second SIP cycle following media transfer.
The “steam off” disconnection of disposable systems minimizes cross-contamination risks associated with reusable components. An increase in productivity, cost-effectiveness, and reduced timelines pose their own challenges in today’s biopharmaceutical manufacturing. Steam-Thru connection, though being a minor component, can make a big difference in overcoming these challenges to a certain extent.
In short, watch the below video illustrating the functional scheme of the component.
Salient Features of Steam-Thru Connections
Following salient features of Steam-Thru connections explains, why it plays an important role in hassle-free sterilization operations.
|Three Port Design||Zero Dead Legs. Hence, no chance of bacterial growth.|
|Single-use or Disposable||Time Saver as reduces cleaning and validation activities and associated documentation.|
|Poly-sulfone MOC||USP Class VI Compliant|
|Steam On||Creates sterile flow path|
|Steam Off||Remove from equipment after sterilization without having a concern over sterility assurance.|
Advantages of Single-use Systems
1. Increased Efficiency
Single-use systems result in increased productivity through the reduction of system maintenance associated with cleaning and validation. This allows manufacturers to increase their output. Also, single-use systems help in reducing hassles of cleaning and validation and associated documentation.
2. Add Flexibility
An equally important factor, flexibility, plays a key role in terms of facility modifications for existing drugs or new facility setup for different drugs. Contrast to hard piping, disposable systems get easy to change for alternative media handling. For instance, implementing single-use technologies helps in production scale-up at an existing facility where traditional fixed systems would normally require costly facility expansion. Also, for new facility setup they are mobile, leaving behind the concerns of validation activities and mechanical modifications.
3. Minimize Risk
Risks not only involve man but also product of concern. Product contamination can lead to loss in product quality. Eventually, expensive reprocessing activities often require preventing the complete loss of a valuable batch of media. As companies now promoting their business with single facility being used for multiple products, this becomes an even larger concern. They pose a terrible impact on productivity and concerns over cross-contamination, a negative impact on company’s reputation. Integrating single-use systems may help in minimizing this possibility.
Resources for cleaning and validation include chemicals, utilities, labor and time. Utilities like WFI and Steam which’re required in cleaning and sterilization activities get consumed in an optimized manner for existing facilities. Also, implementation of disposable system results in capital savings because of less space consumption and accessories with traditional systems.
- Poly-sulfone with Polyethylene Sleeve
- Poly-sulfone with Polycarbonate Sleeve
- USP Class VI
- Color: Amber Tint
- Autoclave and SIP friendly
- Silicone, platinum-cured seal options
- No mounting required, free floating
Where Steam-Thru Connections are used?
- Bio-reactor Feeding
- Cell Harvesting
- Product Sampling
- Single Use Bag Systems
- Media Transfer Lines
Disposable components like Steam-Thru connections help in achieving better control over the process, hassle-free operations, and that too at a cost reduction. Hence, the application of such techniques during sterilization and process operations encourages the companies in method optimization and cost savings. Apart from that, when one such component provides better control, why not consider it for your process?