BUGA-CoL Fibrillar Type I Atelocollagen from Bovine Flexor Tendon Lyophilized, BSE Free
Ürün Bilgisi

BUGA-CoL Fibrillar Type I Atelocollagen from Bovine Flexor Tendon Lyophilized, BSE Free (BUGA- FibriCoL), medikal saflıkta üretilen bir üründür. BUGA- FibriCoL, saflık (> %99,9 kolajen içeriği), işlevsellik ve mevcut doğal kolajen açısından tüm kolajenlerin standardıdır. BUGA- FibriCoL FDA onaylı viral inaktivasyon çalışmalarına tabidir.
TSE/BSE statüsünde olmayan ülkelerden hammadde tedariği yapılarak TSE EN ISO 22442 1-2-3 standardları kapsamında üretim gerçekleştirilir. TSE/BSE kalıntısının olmadığı analiz sertifikasında Avrupa Farmakopisi (EP 2.6.14 Metot C) ve Amerikan Farmakopisi (USP<85>) test metotları ile verilir.
BUGA- FibriCoL; doku iskelesi, sünger yapılar, kaplamalar, filmler ve tabakalar gibi formlarda tasarlanacak ürünler için kolayca hazırlanabilir, hidrojel bir yapı oluşturmaz. Ancak bu malzeme çapraz bağlama yöntemleri kullanılarak, optimal biyomalzeme çalışmaları ve in-vivo emilim için kullanılabilir. BUGA- FibriCoL ürünü doku mühendisliği uygulamaları için idealdir.
• Biomedical
• Natural Polymers for 3D Printing
• Material Science
• Biochemistry
• Cell Culture
• Tissue Scaffolds
• Sponge Structures
• Coatings
• Films and Sheets
• For research and development purposes only.
• Weigh the desired amount of BUGA-FibriCoL fibrillar collagen product and transfer it into an appropriately sized container after determining its concentration.
• Prepare a 0.01 M hydrochloric acid or 0.5 M acetic acid solution according to the volume you will work with after weighing the lyophilized product.
• Mix the lyophilized product with the prepared acid solution in a suitable mixing container (e.g., borosilicate beaker or bottle) at a low RPM (preferably 350-500 RPM) until homogeneous distribution is observed under magnetic stirring.
• If the prepared solution will not be used immediately, store it at +4 °C in a refrigerator.
Note: Freezing the dissolved product is not recommended.
NOTE: Fibrillar collagen inherently has fibrils, so full dissolution is not observed. However, it demonstrates homogeneous distribution within the solvent. Visible fibers in the solution are normal and do not pose a problem.
For Coating Procedure;
• Prepare the solution form of BUGA-FibriCoL as described above.
• Dilute the collagen to the desired concentration using sterile 0.01 N hydrochloric acid solution. Mix gently until the content is fully homogenized.
• Ensure the working concentration is suitable for fibrillar collagen preparation. This concentration should be determined based on specific application needs.
• Adjust the pH value carefully using sterile 0.1 M sodium hydroxide solution until the desired concentration and viscosity are achieved. Monitor the pH value closely (using a pH meter, phenol red, or pH paper).
• Store the prepared fibrillar collagen solution in sterile tubes, ready for application.
Product Technical Specifications
Appearance | Lyophilized white color | |
Smell | No data available | |
Extraction method | Acidic and pH balanced -Fibrillary collagen | |
Sterilization method | Filtration | |
Solubility/Collagen concentration | 1, 3, 6 mg/ml (in 0.01 M HCl) | |
Storage temperature | Store at -20 ºC. After solution, store at 2-8 ºC. | |
Shelf life | 2 years from date of production | |
Solution shelf life | 3 months after making it into solution | |
Collagen purity - Silver staining | ~98,9 | |
Source (Animal type) | Beef tendon | |
Endotoxin/LAL European Pharmacopoeia (EP 2.6.14 Method C) American Pharmacopoeia (USP<85>) | <0,5 EU/ml | |
Microbiological Analysis American Pharmacopoeia (USP<61>) | Aerobic Mesophilic Bacteria cfu/ml |
<10
|
Anaerobic Mesophilic Bacteria (30 ℃) cfu/ml | <10 | |
Mold-Yeast cfu/ml | <10 |