By K.A. Danko, U.S.
Incorporate single-use bottle assemblies into your fluidic pathway.
When developing and producing vaccines and other similar biologics, cleanliness of the entire fluidic pathway is of utmost concern. Ensuring a contamination-free system requires multiple layers of protection, and often the most labor-intensive – and expensive – steps occur when preparing the system for use, with the following being contributing factors:
- Regular use of disposable gloves, masks and other mitigating PPE (Personal Protective Equipment), creating barriers to exposure by possible contamination sources
- Fluidic pathway hardware – such as bottle assemblies (which typically include components such as the bottle, a vented cap, an appropriate vent filter, and tubing) – that must be pieced together and then thoroughly cleaned and qualified prior to use
When fluidic pathway components are used in cleanrooms
Additional complexity (and expense) of the preparation steps occurs when the fluidic pathway components are used in a cleanroom environment. To ensure the system components are free of biological contaminants – which is necessary for cleanroom applications – system components often must undergo high-energy and high-effort decontamination steps, including Clean-in-Place (CIP), Steam-in-Place (SIP), Gamma-Irradiation, and Autoclaving processes. Unfortunately, each of these steps often requires manual handling of the system hardware, and thus carries the on-going time and financial risk of biological contamination.
To help mitigate these inherent risks and to save money in the process one tool you could consider is incorporating Masterflex® Single-Use Bottle Assemblies into the fluidic pathway of your system.
Masterflex Single-Use Bottle Assemblies
Our pre-kitted and pre-packaged bottle assemblies have been designed with vaccine production and cell therapy manufacturing applications in mind. These gamma-irradiated bottle assemblies come ready for immediate integration into your system’s fluidic pathway. They are engineered with a seamless liner equipped with pre-molded TPE fill and vent tubes to create an unobstructed fluidic pathway. The 24” (61 cm) fill tube is plugged at the terminal end to maintain assembly sterility until use. The vent tube is fitted with a 0.2-micron PVDF disc filter to prevent airborne contamination, and the hydrophobic nature of the vent filter offers protection against loss of product during filling or emptying. Additionally, the one-piece liner itself helps prevent bacterial entrapment and contamination by forming an elastomeric seal between the cap and the bottle.
The added benefit of Puri-Flex® TPE tubing
The TPE tubing utilized with these single-use bottle assemblies is manufactured from Puri-Flex, a Masterflex-exclusive material. Puri-Flex offers numerous advantages that are ideal for these types of applications:
- It is USP Class VI, FDA 21 CFR 177.2600 and ISO 10993 Part (S) 4/5 compliant to ensure easy acceptance into highly regulated environments
- It is both sealable and weldable, facilitating the formation of contamination barriers
- It offers low gas permeability, reducing the exposure of expensive samples to atmospheric gasses
- It is chemically compatible with a wide range of reagents, including both acidic and alkaline solutions, helping ensure worry-free use in most systems
- Its smooth inner surface reduces platelet adhesion and protein binding, leading to an increased production yield and a reduction in sample loss
Masterflex Single-Use Bottle Assemblies are kitted together in an ISO Class 7 cleanroom environment and are gamma-irradiated up to 40 kGy. Each assembly is packaged in a single bag with a cleanroom/gamma dot incorporated onto the label for added assurance. For more information about these time- and cost-saving bottle assemblies, please contact your local Cole-Parmer representative.
Sign up for our Single-Use Webinar, Thursday, August 20, 2020!
Learn more about Vaccine Research and Development: Vaccine Development: Pathogens Fighting Disease