What we can do to meet the clinical customers needs?
The staple made by high-quality titanium for medical suture. Not only need to have sufficient strength to resist the tissue rebounding which were compressed, also need such characters as below:.
1.Excellent biocompatibility, avoid body difference reaction or aseptic inflammation.
2. Material is corrosion resistance, and will not bring the potential difference with tissue or tissue juice.
3. Does not generate factor of cancer-causing
4.Does not obstruct diagnostic imaging
Titanium alloy and pure Titanium
The tensile strength and yield strength of titanium alloy contrast pure titanium are 4 to 1. The staple made by titanium alloy have sufficient strength to resist “B” type staple which could resist the tissue rebounding and huge tension formed by flatulence after the gastrointestinal tract be sutured, so avoiding the “B” staple open to reduce bleeding and leakage.
The Titanium is being selected more and more often as the “metal of choice” for applications where corrosion resistance, light weight, strength and biocompatibility. The industry leader has broad experience in a wide variety of applications, ranging from titanium weld wire to surgical suture. Meanwhile who must is certified to the standard AMS, AWS and ASTM specifications as well as individual customer specifications.
What we can do to meet the clinical customer needs?
Excellent medical stainless steel products or installation kit, require high accuracy、 excellent performance and excellent biocompatibility.
About material, we should consider not only corrosion resistance, tensile strength, yield strength, toughness, fatigue resistance, hardness and wear performance, but some professional alloys even have good homogeneity and good microstructure. Certainly higher annealing strength and more consistent mechanical properties and physical properties are also very important.
About the precision metal processing, the use of automated control of water cleaning system, will enable the cleanliness of the hospital operating environment., and achieves the highest medical standards, even gets the qualified certification of human implants. The processing environment is super clean, free from contamination and being taken security measures.
Secondary processing procedure, although there are all details, but even many important processes such as: Cleaning-up burr, electroplating, electro-chemical cleaning-up burr, strengthen, laser welding and laser lineation, heat treatment, parts galvanization etc. If there is a little bit deviation, which will probably impact the quality of finished products.
Bigant use imported medical stainless steel, apply the most advanced precision metal processing technology and post-treatment process, in order to meet even exceed the quality of international standard.
How can we ensure the firing 100% successful in operation?
Right solution relates to:
1.The feasibility study and reliability of test fire proposal.
2.The long term stability of material and installation kit.
3.If the internal quality control standards can close enough to meet the 6 SIGMA System Requirements.
Over the years, large-scale internal pre-manufactured tests show that:
The state of the disposable staplers after many times testing fired show, the first time to the fifth time has highest rate of failed, from the sixth time, it shows few. So Bigant brand products definite have six times testing fired before come out the factory, after insuring success, we reload the staples seventh time then enter market for selling.
In order to avoid small quality gap between differences lots of materials and installation kit, even deflection to the tolerance of normal fluctuation due to different periods of time. Bigant internal order that every 100 small batches of products required to randomly selected three pieces to firing repeated until it damage. This damage type of destructive experiments, must make sure these 3 pieces are all fired successfully for more than 12 times, after then this lot would be permitted to enter finished products test phase(6 times test fire).
On the other hand, the QAQC team of Bigant has huge number persons, does 6-sigma system quality control for each process, let each Bigant products have the only one bar code and matchup EAN international, insure each products is retroactive effect.
What we can do to meet the clinical customers needs?
Excellent security of medical products package, need to
ensure the products stabilization, efficiency, and safety during manufacturing, transport and storage.
Good packaging is not only a package with good sealing performance, but also has a good opening, well germ barrier, so that ensures effective sterilization.
In addition, good packaging also stress the continued stability of the performance, as well as the phase of adaptation, material blocking microorganism and non-toxic extending from requests of sterilization and sterilization course.
PETG
Eastman® Polyester PETG is a clear transparent sheet made from thermoplastic copolyester. It is one of the most respected and trusted plastic sheets around. It offers extreme clarity and light transmission in combination with high gloss. Polyester PETG sheets have very good impact resistance, even at low temperatures, and are approved for food contact applications. Polyester PETG sheet has outstanding thermoforming properties, combining low energy consumption, short production cycles, extreme draw ratios and good mould reproduction without the need for pre-drying. Polyester PETG is easy to screen print, and offers ease of fabrication.
TYVEK®
DuPont™ Tyvek® brand protective material has been recognized as a standard of excellence for medical packaging. Tyvek® brand protective material offers an optimum balance of microbial penetration resistance, tear strength, puncture resistance and clean peel, as well as compatibility with existing and new methods of sterilization. The secret to the superior performance of Tyvek® is that it’s not a paper, but rather a sheet of flash spun and bonded high-density polyethylene (HDPE) fibers. Continuous strands of very fine, interconnected fibers are randomly oriented and bonded together by heat and pressure during manufacture. The result is a tough, durable sheet structure that provides a unique combination of physical properties that no other sterile packaging material can match. Tyvek® has become a standard of excellence against which other sterile packaging materials are judged. The number-one priority in selecting packaging materials for medical devices is the ability of the package to maintain sterility from the point of sterilization until the product is opened for use. Even under the most rigorous conditions in highly contaminated environments, Tyvek® is highly resistant to penetration by bacteria spores and other contaminating microorganisms. Bacteriological tests clearly demonstrate that Tyvek® outperforms other commercially available porous packaging materials, including medical-grade papers. Comprehensive shelf-life studies have shown that Tyvek®can maintain sterility for at least five years if package integrity is not compromised. The tough, continuous fibers of Tyvek® protect package integrity from product breakthrough and also from penetration by an object outside the packaging during rough handling. Compared to medical-grade papers, Tyvek® provides superior puncture resistance and tear strength, which means that Tyvek®does not puncture easily and tears do not readily propagate if a package is nicked. Tyvek® is up to eight times stronger than medical-grade papers of equal or greater basis weight, so it resists punctures—even from the irregular or sharp edges of many surgical devices. In contrast, one small tear in a package made of medical-grade paper can contaminate a sterilized device and compromise the entire sterile field.
Gumming
Bemis Co. is a leading manufacturer of flexible packaging in the world, which gelatinizes for TYVEK® paper, could satisfy the requirement of disposable high-end medical device products, due to can meet those hard requirement of clean sealing, integrity and strength.
Bigant apply advanced PETG Trays and thicker TYVEK®1073B cap material, the heat seal coated machines have high-precision, good efficiency and best stability. These can make sure their disposable medical packaging products are 100% safety.