Overview

• Post By : Chinmaya Ranjan Parida


• Source: Ami Polymer Pvt Ltd


• Date: 11 May,2025

In the case of biopharmaceuticals, industry standards demand that during every step of the vaccine or biologics manufacture processes, sterility and integrity of these bioprocesses is sustained. critical part of this is the ability to collect process fluids at predetermined time intervals for analysis without introducing any contamination.

This is where a Sampling Manifold in a Single-Use System (SUS) becomes extremely useful.

What is a Sampling Manifold?

In the case of single use systems, a sampling manifold is an all-in-one, gamma irradiated, sterile and single use set up intended for sample retrieval from bioreactors or process containers. It enables users to perform numerous sample collections at various intervals without stopping the process as well as without bringing any sterilization risks to the system. Usually, the setup contains 5 or more sampling bags linked through 3-way stopcock valves which control movement between each bag. There is a sampling needle on the inlet that is placed in the bioreactor or container and the outlet of each bag has a needleless sampling port which enables sterile sample retrieval for real time assessment.

Why to Use a Sampling Manifold?

The need for a sampling manifold arises from the requirement to:

1. Maintain monitoring activities of critical quality attributes (CQAs) such as pH, dissolved oxygen (DO), glucose, cell density.
2. Ensure that sterility is checked for at various levels of the production process.
3. Test samples at different stages without breaking aseptic conditions.
4. Compared with traditional stainless-steel systems, there is lower risk of cross-contamination, human error, and cleaning validation.

Primary Parts of a Sampling Manifold:

Sampling Needle:

1. The first point of contact with the bioprocess fluid, it is commonly made from SS316L steel.
2. It is inserted into the bioreactor or container to draw samples aseptically.

Three Way Stopcock Valves:

1. As controllers of flow to each sampling bag from the sampling needle, these valves are very important.
2. Each operator can control their own sample by turning the valve, allowing for time-separated sampling.

Sampling Bags (2D Bags):

1. The volume of these 2-port bags from 50mL to 500mL, depending on the volume required. Made from pharmaceutical-grade film, these bags are.
2. One port will connect to the tubing of the manifold and the other will be for sample withdrawal.
3. The design of the bags is such that the sterility and sample integrity is maintained for a long duration.

Needleless Sampling ports:

1. These ports are connected using female luer locks to the tubing of the sampling bag.
2. The effort to remove samples from the container without risking any contamination can be done because no rubbing alcohol can be pierced and removed with a syringe.

Drainage Bag:

1. Used to contain any overflow or waste fluid sample that needs to be collected, this bag sits at the lower part of the system.
2. Usually measured from 100 ml up to 1 liter, depending on how much overall sampling can be done.

Advantages and further Attributes includes:

Ready to use and Presterilized:

1. Every sampling manifold is pre-sterilized and assembled in a clean ISO class 7 boxed room.
2. This removes the need of cleaning or autoclaving on the site.

Flexible Customizable Design:

Customers along with other user are allowed to choose how many sampling bags plus changing the length of the tubing and materials like TPE, Silicone, etc to be used, and the type of connectors like MPC, MPX, Luer and others that would be used depending on the user’s processes.

Works with Other Single-use Bioprocess Equipment:

These manifolds seamlessly integrate with single used bioreactor, mixer bags and media bags which makes them ideal for upstream and downstream process.

Minimal risks and reduced downtimes

Since these systems are disposable, there is a significant amount of decreased downtime due to cleaning, maintenance validation and others make these systems cost effective and efficient.

Conclusion

In biopharma manufacturing, the sampling manifold is both simple in design and elementary for safeguarding product quality and process consistency.

These systems, with a focus on sterility, ease of use, and versatility, are already implemented in facilities using single-use technology for vaccine production, biologics development, and other purity-sensitive fields. Its adoption improves not only product safety, but also meets the increasing demand for bioprocessing solutions that are disposable, easily scalable, and contaminate-free.