Worry no more if you’re unsure about which type of vessel to use for specific purposes while meeting stringent regulatory standards—you’ve landed on the right blog. Vessels are made from various materials, each designed for a specific use.
Here, we categorize the types of vessels used in Grade B environments by material and application for easy understanding. Join TSA to learn more!
Based on Material
The stainless steel vessels are most commonly used due to their durability, reusability and corrosion resistance. However, glass-lined vessels and single-use vessels are preferred for various reasons. Check out to learn more:
1. Stainless Steel Vessels
These vessels are made from high-quality steel, which is 316 stainless steel, as it is resistant to corrosion and can be cleaned easily. They are usually electropolished to a smoothness of less than 0.5 microns to minimise microbial adhesion and help maintain sterile conditions. They can have integrated CIP and SIP systems to avoid contamination between batches, reduce downtime delays, and ensure compliance with GMP.
A stainless steel mixing tank is essential to prepare pharmaceutical solutions, suspensions, and emulsions. These mixing tanks have special agitators for uniform mixing to achieve consistent product quality. Stain steel storage tanks are used to hold raw materials, intermediates and finished products.
2. Glass-Lined Vessels
In the pharma industry, the glass-lined vessel is paramount to handling reactive, corrosive, or sensitive materials that cannot directly come in contact with metals. Such vessels have a base of stainless steel and are lined with a layer of glass to provide a non-reactive, smooth surface, as it helps avoid contaminations due to corrosion. The Glass-Lined vessels are suitable for processes requiring stringent purity standards.
These vessels are often used to produce active pharmaceutical ingredients that involve harsh chemicals. The inert layer of glass protects the vessel and its contents, thereby allowing it to be used for storing acids, bases, and solvents.
Typically, these vessels range from lab-scale (10 L) to large industrial scale (several thousand litres), making them versatile for small and large batches. Since many of these vessels are jacketed, the temperature can be precisely controlled to maintain reaction conditions consistently.
Source: Freepik
3. Single-Use Disposable Containers
The Single-Use Disposable Containers are made from medical-grade plastics such as polyethylene and polypropylene. Since these containers are pre-sterilized and can be used only once, they save time on cleaning and sterilization and prevent any risk of cross-contamination.
Where the traditional containers require extensive cleaning, validation, and sterilization that increases the risk of contamination if not done correctly, the disposable containers are discarded after each use. This is paramount in Grade B areas, requiring air quality to be meticulously controlled and maintained at a high level to prevent contamination. Thus, these single-use containers help maintain sterile conditions throughout the process.
However, one must confirm these single-use containers adhere to the stringent regulatory standards to ensure product safety. The FDA and EMA enforce guidelines on the materials used, integrity testing and leachable studies to guarantee that these containers do not compromise the quality of products.
Based on Application
Depending on the variety of processes, the vessels are designed to meet the needs of the intended application. Here are some of the commonly used vessels :
1. Pressure Vessels
Pressure Vessels are made from 316L stainless steel and are designed to handle pressurised contents. They are used for high-pressure mixing processes, especially in sterile areas with high contamination risk. To prevent any mishap, they have safety features like pressure release valves and are compatible with CIP/SIP systems.
TSA offers intelligent solutions to save time, deliver cost optimisations, and protect your process. Choose CIP/SIP systems that incorporate static or dynamic spray balls working in tandem with temperature, time duration, and spray concentrations to sanitise your equipment thoroughly. Customisation options include Tank or no Tank CIP system, Hex, dosing system, One or Two tank CIP, pump designs, Centralised CIP, local recirculation skids, combo CIP-SIP system and a complete qualification and validation package.
2. Portable Vessels and Drums
These vessels can be either made from stainless steel or autoclavable materials. Since a portable vessel is required to transport ingredients and products within the Grade B area, they have wheels and handles for easy movement and are also designed for easy cleaning.
They are chosen based on the processes, product compatibility, and the level of cleanliness required.
3. Aseptic Transfer Vessels
As the name suggests, these vessels are used to transfer materials between Grade B and Grade A areas while minimizing the contamination risks. It has tight-sealing ports and valves to ensure sterility during transfers.
They are usually made from 316L stainless steel with a smooth internal finish to avoid any contamination and have an electropolished surface with Ra≤ 0.4 microns. These vessels typically have a capacity ranging from 20L to 200L. For ease of transport, they have ergonomic handles and wheels/trolleys. It has aseptic ports for closed transfer.
4. Mixing Tanks
A mixing tank is made from stainless steel and is used for blending, mixing, and preparing pharma solutions, suspension, and other intermediates. Depending on the production scale, its capacity ranges from 50L to 2000L.
Depending on the product type, these mixing tanks have low-shear or high-shear mixers/agitators. These tanks usually have CIP/SIP systems for automated cleaning and sterilization.
5. Storage Tanks /Holding Vessels
They are used to temporarily store/hold raw materials, intermediates, or finished products. These vessels may not necessarily be made from 316L stainless steel. Sometimes, 304 stainless steel vessels also store non-reactive and inert storage.
TSA manufactures holding vessels designed to store sterile products under positive nitrogen pressure. Each vessel is pre-sterilized with pure steam before filling. Variables such as product mixing, temperature, and pH controls are available. After passing through a sterile filter, the product is transferred to the filling line via pump or nitrogen pressure. Product recirculation is available for specific products.
We offer customisations, including movable or fixed skid systems, jacketed, limpeted or plain insulation options, CIP/SIP integrations, level sensing, load cell, DPT or radar systems.
Its capacity ranges from 100L to several thousand litres per storage need. They often have sanitary clamps or gaskets to maintain sterility and avoid leakage. These are usually mounted on casters to move them easily within the cleanroom.
6. Reactors
Only 316L Stainless Steel or glass-lined vessels are used to produce APIs and other active ingredients where chemical reactions occur. Its capacity ranges from 10L for lab-scale to over 1000 L for industrial-scale production.
These reactors are designed to withstand pressures, can tolerate pressure between 1-5 bar and have pressure-relief valves for safety. Their internal surface is highly polished for easy cleaning and control of contamination. A Reactor is often equipped with a jacket to control temperature.
6. Buffer Preparation Tanks
In biopharmaceutical processes, various buffer solutions are required for different purposes. The tanks made from 316L Stainless Steel are preferred to avoid contamination due to corrosion.
These tanks have low-shear agitators to prevent bubbling. Often, CIP/SIP systems are integrated to maintain sterility.
Choose the most Reliable Process Vessels for buffer preparation as they are designed with the QRM/QRS approach in accordance with ASME/BPE/PED guidelines and are available in capacities ranging from 5L to 50000L.
We offer customisations such as jacketed or insulated, mobile skid or fixed in place, CIP/SIP integrations, top or bottom mounted mixing, seal or magnetic, and Automatic, Semi-Automatic, or manual. Additional options include level sensing, load cell, DPT, and radar systems.
Check the video of TSA process vessels here:
Propofol Emulsion Manufacturing Plant by TSA Process Equipments
7. Weighing and Dispensing Vessels
316L Stainless steel is used to design these vessels for weighing and dispensing raw materials before introducing them into the manufacturing process. The capacity generally ranges from 5L to 50L only and is ergonomically designed with wide openings for easy access and precision dispensing. These vessels are electropolished to ensure low particle adhesion.
Conclusion
As we conclude this discussion, we are eager to hear from you. Let’s further explore your unmet needs in the pharma industry to craft tailored solutions. At TSA, we understand the importance of customisations– tell us what you need. Contact us today!
Frequently Asked Questions (FAQs)
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How do I choose the right vessel for my Grade B facility?
The choice of vessel depends on factors like the nature of the product (e.g., liquid, powder, biological material), batch size, and sterility requirements. Considerations include the vessel’s material, size, ease of sterilization, and whether single-use or reusable options are preferable.
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What are extractables and leachables in single-use vessels, and why are they important in Grade B environments?
Extractables and leachables refer to chemicals that may leach from the plastic materials of single-use vessels into the pharmaceutical product. In Grade B environments, it’s essential to test for these substances to ensure that they do not compromise the safety or efficacy of the product.
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What are the regulatory requirements for vessels in Grade B pharmaceutical environments?
Vessels used in Grade B environments must comply with regulatory guidelines set by authorities such as the FDA, EMA, and ISO. These regulations cover aspects like material safety, sterility validation, leachables/extractables testing, and cleaning protocols for reusable systems.
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How are vessels validated for use in Grade B environments?
Vessels must undergo rigorous validation, including sterilization, integrity testing, and material compatibility assessments. Validation ensures that vessels meet the sterility and quality standards required for pharmaceutical-grade cleanrooms.
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What are the cleaning requirements for reusable vessels in Grade B areas?
Reusable vessels in Grade B environments must undergo stringent cleaning protocols, including washing with specialized detergents, sterilization via autoclaving or other methods, and regular validation to ensure no contamination risk.
