Sterility between processes in biopharmaceutical and pharmaceutical lab settings is immensely important for maintaining accuracy, preventing contamination, and even ensuring the safety of operators. Sterility assurance is possible with a closed-loop sampling system. Following is a deeper look into this matter that considers the importance of bridging manufacturing and analytical quality by maintaining sterility between processes.
Establishing a Strict Aseptic Transfer
When promoting sterility, one important factor is establishing a strict aseptic transfer. This process involves sterilizing tools, inoculating loops, and limiting the time that sterile media vessels are exposed to air. Following is a more detailed breakdown.
Steps required before beginning the transfer include:
- Disinfect workspace: To ensure that a workspace is sterile, experts recommend cleaning it with at least 70% ethanol or another industry-approved disinfectant, then allowing it to dry.
- Wear personal protective equipment (PPE): A lab coat, a face mask, and gloves should always be worn tomaintaina sterile environment.
- Organize materials: Situate all sterile instruments, cultures, and media, and place in easy reach within the work area.
- Decontaminate equipment: Sterilize all instruments, pipettes, and glassware using autoclaving, irradiation, or other approved methods.
During transfer, the following steps must be considered:
- Flame the tools: Heat up the needle or inoculating loop until red-hot, then allow cooling for 15–30 seconds before using (prevent the heated equipment from touching anything while hot).
- Sterilize bottle and tube necks: Before opening fully, flame the neck of the tube or bottle, which creates an updraft that forces airborne contaminants away from the opening.
At the open and transfer stage, steps include:
- Handle tubes properly: When opening tubes, hold the cap in hand, never setting it down. The open end of the tube should be held as close to the flame as possible to prevent contamination.
- Use a sterile tool: Use a sterile tool to pick up a small amount of the culture. Avoid unnecessary movement, which can create aerosols.
- Flame the neck: The neck of the receiving tube should be flamed immediately after picking up the inoculum, before inserting the inoculum.
When resealing and resterilizing, remember to:
- Flame: Flame the neck of the receiving tub once again before removing the inoculum and replacing the cap.
- Sterilize: Sterilize the inoculating tool again before setting it down.
After the transfer, ensure that you:
- Seal containers: Seal multi-well plates with tape and then place them in resealable bags, which prevents microbial entry.
- Clean up: Properly discard any used disposable materials and disinfect the work area again.
To summarize, a robust aseptic sampling solution in biopharmaceutical and pharmaceutical processes minimizes the risk of contamination and enables accurate, representative sample collection for reliable process control.
Utilizing a Closed-Loop Sampling System
Another way to promote sterility between processes and a preferred method in many industries includes implementing a closed-loop sampling system. This includes drawing fluid into a sealed container, with excess fluid returning to the main process. This ensures that the sample isn’t exposed, nor is the operator. Following is a breakdown of this process.
- Containment: The core principle of a closed-loop system is total containment. A sample is collected in a sealed bottle with a self-sealing septum cap or sealed cylinder.
- No exposure: Because of the design of the system, fluid flows from the main process line through the sampling point back into the main process. At no point is fluid exposed to open air.
- Needle assembly: In a liquid system, the needle assembly is used to pierce the self-sealing septum of the sample bottle. Once the sample is taken, the needle is withdrawn and the septum seals automatically.
- Representative sample: The continuous flow processes the fluid through the sample point, which ensures a fresh, representative sample, free of dead volume or stagnant product.
In lab sterilization and bioprocesses, closed systems are vital for maintaining an aseptic environment.
Advantages of This Type of System
There are many advantages of a closed system over other forms of sterilization. Here’s a look at more ways in which it can be used to enhance sterility between process and lab.
- Enhanced safety: Protects lab personnel from potentially hazardous or high-pressure process fluids, preventing exposure.
- Prevents contamination: Another benefit is eliminating the risk of external contaminants in the sample, such as fungi or bacteria. This ensures a sterile sample or process stream.
- Ensures sample integrity: In a closed-loop system, the sample remains under process conditions, that is, specific temperature and pressure. This prevents fractionation, or evaporation, which can alter the composition before its analysis.
- Reduces waste: Excess process fluid is returned into the main system instead of being flared or discarded, which can reduce waste.
In summary, a closed approach strengthens safety, preserves sample quality, and keeps processes cleaner and more efficient from start to finish.
Single-Use Assemblies
When creating a sterile environment for a lab setting, another key factor to achieve this is single-use assemblies to be used in a variety of settings. Single-use products ensure the safety and effectiveness of medical devices and pharmaceuticals in labs or in healthcare. This prevents infections and other adverse events that can result from microbial contamination. Keys to selecting single-use products include the following key aspects.
- Design and materials selection: Single-use products must be properly designed and use the right materials. Non-porous impermeable materials are usually preferred when dealing with microorganisms.
- Packaging: Single-use products are sealed in sterile packaging, like blister packs, trays, or pouches, to maintain sterility until the product is ready for use.
- Manufacturing process: The manufacturing process for single-use products must be validated to ensure there is no contamination during production.
- Sterilization methods: Sterilization methods for single-use products should include the use of ethylene oxide gas sterilization, X-ray irradiation, gamma, electron beam sterilization, and steam sterilization. The choice of method should be based on the product’s materials.
Note that while the main considerations are listed here. There are additional factors that should be taken into account when ensuring a single-use product is sterile.
Bridging Manufacturing and Analysis and Maintaining Sterility
Maintaining sterility between process and lab is essential for protecting sample integrity, operator safety, and analytical accuracy. By combining strict aseptic practices with closed-loop sampling systems and validated single-use assemblies, organizations can bridge manufacturing and analytical environments while reducing contamination risk and ensuring reliable results.