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Dear Readers, Welcome to the latest issue of The Magazine
Tubing are hollow Polymeric extruded structure which allows critical fluid transfer during biopharmaceutical operations like Media transfer, Disinfectant application, fluid transfer, Downstream & Upstream applications, Tangential flow filtration, Media fill trial, Fill finish, SIP, CIP, Aseptic welding & Sealing etc. These tubing should be able to withstand various sterilization processes, the delivery of favourable test results regarding extractable substances, and the absence of animal-derived ingredients. Flexibility, permeability, performance in pumps, welding and sealing capabilities are also common considerations.
Tubing should be manufactured inside classified and controlled clean room area. One of the most important concerns involves ingredients. Those derived from animal sources are typically undesirable because of their potential effects on finished pharmaceutical and biopharmaceutical products. Silicone Oils found in some tubing materials can also be detrimental to the end product.
Another crucial topic is validations and extractable studies. Certain tubing materials like platinum-cured silicone are inherently purer than peroxide-cured silicone and offer fewer substances that can be drawn out. Users of Single-Use tubing need to be aware of tests that should be performed to confirm that any extractable in the tubing’s make up do not have an affect the product flowing within. Validations are also important, as they verify that the tubing selected has gone through necessary testing.
Coming to the point, even though tubing may look simple, but the criticality is severe. As products are passed through these tubing, more care and attention is needed while selecting the suitable tubing. The following are some points which needs to be kept in mind during tubing / Hose selection.
The most important consideration in the selection of suitable tubing for any application is the compatibility of the tubing material with the media to be contained. The minimum and maximum operating temperatures for the various tubing materials are also to be considered during selection process.
Today’s pharmaceutical and biopharmaceutical manufacturers have found that the best way to eradicate animal ingredients and their possible effects on finished products is to start with processing components that do not contain any animal ingredients or animal-derived ingredients. Another substance that can be troublesome is silicone oils. The oils can react with other components and leave a residue in the final product. Check with supplier to find out if tubing contains animal-derived ingredients or other undesirable elements.
Although tubing is sterilized prior to use, it makes sense to start with the cleanest possible product. Learn about the conditions in which the tubing is manufactured. The clean room manufactured product will be free from foreign particles which may contaminate the product in contact. Better to have information about how your tubing is produced. Is it produced in a clean room? If so, what level (ISO 6, 7, 8)? How is it handled and stored after manufacture? Has it been tested for contaminants by an independent laboratory?
For regulatory market application tubing shall meet all your regulatory requirements like USP, FDA, ISO, BPOG, EU, TGA, ANVISA.
Autoclave (steam sterilization), EtO (ethylene oxide) gas treatment, gamma irradiation. These questions should be researched or posed to suppliers to help you make an informed decision. Another point to consider is whether you will receive tubing that is pre-sterilized or if you will handle that process. If you’ll be ordering pre-sterilized tubing, you need to make sure that the supplier’s process has been validated to the degree of sterilization necessary.
Absorption, adsorption, and permeability Absorption (the penetration into the mass of one substance by another), adsorption (when molecules of a substance collect on the surface of another), and permeation (the diffusion of one substance through another substance) are details to examine when evaluating tubing. Materials differ greatly in how they contribute to these factors, and the fluids or gases for which the tubing is intended need to be considered. TPE (thermoplastic elastomer) tubing, for example, is much less permeable than typical silicone tubing. How does the tubing material you’re considering perform when it comes to these elements? Consider this if you use preservatives in your product.
Tubing materials like platinum cured silicone are inherently purer than peroxide-cured silicone and offer fewer extractable (substances that can be drawn out of a material). Testing should be performed to confirm that any extractable or substances in the tubing’s makeup do not adversely affect the product flowing through it and vice versa.
Has the tubing you’re considering undergone the necessary tests to ensure its suitability for your application? Without validated test certifications, you may put your products, as well as lives, at risk.
Pharmaceutical and biopharmaceutical manufacturing often involves the retention of batch samples, which are specimens of the drug or substance being produced. These liquid samples are frequently stored in small bags with tubing attached or within a section of the tubing itself. This tubing must be permanently sealed without breaking sterility, preferably inner wall to inner wall using heat and compression, to prevent spillage and contamination. Tubing materials such as silicone cannot be heat sealed and require the use of mechanically applied fittings or connectors to stop flow or to join two pieces of tubing together. Other materials like thermoplastic elastomers work very well in typical heat sealing processes. Tube welding – a procedure where two open ends of tubing are thermally and permanently connected to each other – is another common function often employed in pharmaceutical and biopharmaceutical manufacturing. As with heat sealing, silicone cannot be welded but TPE’s can.
Many pharmaceutical manufacturers use a peristaltic pump and silicone tubing in their processes. But as noted above, tubing that can be heat sealed and welded is often needed at some point along the fluid path. Some manufacturers use one material for certain sections of their process, connect a piece of silicone tubing for the peristaltic pump section, and then return to the first tubing material. This setup involves multiple barbed fittings, cable ties, and the potential for leaks and contamination, as well as human error. Situations have even occurred where an operator has installed the wrong section of tubing in a pump, resulting in lost pharmaceutical product, equipment replacement, and hours of time and labour. Tubing material such as TPE’s meet the requirements for a flexible, high purity, peristaltic pump tubing that may be welded and sealed, thereby eliminating multiple materials.
Like silicone, certain TPE’s can be moulded into connections such as Y’s (wyes) and T’s (tees), further reducing the need for fittings and the possibility of leaks. Consider whether a single tubing material can be used in your application.
Today’s fast-moving world has come up with SUS and customisation. The supplier shall be capable of providing customisation in short notice, shorter delivery periods and solution provider.
During manufacturing due to various applications, at times tubing and hoses are needed in same MOC. This is a major challenge with various suppliers. M/s Ami Polymer Pvt Ltd, India is having solution to these type of challenges. You can rely on Ami Polymer P Ltd for Quality product, with ease of customisation and shorter delivery periods. Pl contact Ami Polymer P ltd for your samples and queries.
Since 1998, Ami Polymer Pvt ltd (APPL) is in business of Silicone Elastomeric products and also, other Polymeric components which ultimately provide solutions to Fluid transfer, sealing and Contamination control for Biopharma, Pharma, Medical, Laboratory, Food, Beverages and engineering sectors worldwide.
APPL having ISO CLASS 7 & 8 Clean room facilities with all certifications which will meet all your regulatory requirements. Pl visit & contact www.amipolymer.com for more details.
Name- Kabirdas B
Email- kabir@amipolymer.com
Website– www.amipolymer.com
