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용혈성시험 - Hemolysis assay (PRODUCT #: K003)

Hemolysis test kit (30 determinations)

Hemolytic activity is a requirement to be tested for any blood contacting medical device

file용혈성시험_Hemolysis_Assay_Kit.pdf fileBiomaterial_Hemolytic_Assay_Kit_Insert_February_2022.pdf fileMSDS_Biomaterial_Hemolytic_Assay_180518.pdf
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용혈성시험

발전하는 의약산업과 더불어 강화되는 GMP 및 시험 규격에서 국내 회사들이 국제적인 표준에 걸맞는 시험, 규격과 감사를 실시하고 있습니다.

국내 의료용구 제조처 , 주사수액 제조처 및 위탁시험에서 반드시 필요한 시험 항목으로 간편하고 첨단적인 용혈성 시험 키트를 소개하여 드리고자 합니다.


<국내>

KP 일반시험법의 수액용 고무마개시험법에서 수액용 주사제에 쓰이는 용기중 내용량100 mL 이상의 용기를 막는데 쓰는 고무마개 (플라스틱 등의 재료로 코팅 또는 라미네이트한 것 포함)를 말한다.

고무마개는 내용 의약품과 물리적 또는 화학적으로 작용하여 그 성상 및 품질에 영향을 미치지 않고 미생물의 침입을 방지하며 수액을 쓰는데 지장을 주지 않는 것으로 다음 규격에 적합하다 .

• 카드뮴

•납

• 용출물시험성상 , 거품, pH, 아연, 과망간산칼륨환원성물질

• 급성독성시험

• 발열성물질시험

• 용혈성시험


<해외>

1. The major compendial standards are: the United States Pharmacopoeia (USP)<381>"Elastomeric Closures for Injections,“

2. European Pharmacopoeia (Ph. Eur.) 3.2.9, "Rubber Closures for Containers for Aqueous Parenteral Preparations, for Powders, and for Freeze Dried Powders,“

3. Pharmacopoeia of Japan (JP), Section 59, "Test for Rubber Closure for Aqueous Infusions,“ International Organization for Standardization (ISO).


기존의 용혈성 시험에대한 문제점으로 거론되는 점은 아래와 같다 .

1.  많은 시간과 번거러운 탈 섬유혈 조제과정

2.  용혈현상에 대한 애매모호한 시험자의 육안판정

3.  용혈성분에 주된 침출액, 독소, 금속이온, 표면이온 및 불특정 혈구 용해물질의 성분에 대한 양성 대조액 부재

4.  정량된 수치의 부족


이러한 문제점을 해결하기 위해서 저희는 세계적인 네덜란드 생명 공학 회사 HAEMOSCAN의   용혈성 시험에 대한 첨단기술과 지식을 소개하려고 합니다. 고객 여러분들께 간편하고 정확하게 용혈성시험 Hemolytic kit를 사용하는 제품을 소개하여 드리겠습니다. 관심있는   분들은 저희 주소로 문의하여 주시기 바랍니다.


Description

Hemolytic activity is a requirement to be tested for any blood contacting medical device. The test is based on erythrocyte lysis induced by contact, leachables, toxins, metal ions, surface charge or any other cause of erythrocyte lysis. The current description is based on direct contact of biomaterial and an erythrocyte suspension. The method is based on release of hemoglobin, which can be measured spectrophotometrically. This method is suited to evaluate the hemocompatibility of biomaterials and medical devices according to the international standard ISO 10993-4:2002.

Application

Measuring biomaterial induced hemolysis. This kit is intended for laboratory research use only and is not for use in diagnostic or therapeutic procedures. The analysis should be performed by trained laboratory professionals.

Principle

An erythrocyte suspension is incubated for 24 hours with test material during rotation at 37 ºC. Before and after incubation samples are collected and centrifuged to obtain supernatant, containing free hemoglobin. The hemoglobin concentration is measured by means of a spectrophotometer. Test samples are compared to reference materials. Positive reactive and less-reactive reference materials are included in the kit. It is recommended to include at least two reference materials in each analysis.
The results of the tested materials in relation to the reference materials may be used to evaluate the hemolytic activity. It must be noted that pass/ fail criteria are based on 2% hemolysis. Thus, also the total hemoglobin concentration of the used erythrocyte suspension must be determined.
The kit is designed to determine hemolytic activity of small biomaterial samples. Larger samples can also be used as long as the ratio between erythrocyte suspension and material size is respected.


Storage and Stability

Product is stable at -20 °C for at least six months.


References that used the Hemolysis assay:

  1. Virk, HS, Popat, KC. Erythrocyte interaction with titanium nanostructured surfaces. In vitro models. 2022;1:347–363.

  2. Li, X, Ilk, S, Liu, Y, Raina, DB, Demircan, D, Zhang, B. Nonionic nontoxic antimicrobial polymers: indole-grafted poly(vinyl alcohol) with pendant alkyl or ether groups. Polym. Chem. 2022;13(16):2307-2319.

  3. Swithenbank L, Cox P, Harris LG, Dudley E, Sinclair K, Lewis P, Cappiello F, Morgan C. Temporin A and Bombinin H2 Antimicrobial Peptides Exhibit Selective Cytotoxicity to Lung Cancer Cells. Scientifica (Cairo). 2020 Jun 26;2020:3526286

  4. Yu R, Wang J, So LY, Harvey PJ, Shi J, Liang J, Dou Q, Li X, Yan X, Huang YH, Xu Q, Kaas Q, Chow HY, Wong KY, Craik DJ, Zhang XH, Jiang T, Wang Y. Enhanced Activity against Multidrug-Resistant Bacteria through Coapplication of an Analogue of Tachyplesin I and an Inhibitor of the QseC/B Signaling Pathway. J Med Chem. 2020 Apr 9;63(7):3475-3484.

  5. Franco AR, Fernandes EM, Rodrigues MT, Rodrigues FJ, Gomes ME, Leonor IB, Kaplan DL, Reis RL. Antimicrobial coating of spider silk to prevent bacterial attachment on silk surgical sutures. Acta Biomater. 2019 Nov;99:236-246.

  6. Wersig T, Krombholz R, Janich C, Meister A, Kressler J, Mäder K. Indomethacin functionalised poly(glycerol adipate) nanospheres as promising candidates for modified drug release. Eur J Pharm Sci. 2018 Oct 15;123:350-361.

  7. Shi J, So LY, Chen F, Liang J, Chow HY, Wong KY, Wan S, Jiang T, Yu R. Influences of disulfide connectivity on structure and antimicrobial activity of tachyplesin I. J Pept Sci. 2018 Jun;24(6):e3087.

  8. Leszczak V, Popat KC. Improved in vitro blood compatibility of polycaprolactone nanowire surfaces. ACS Appl Mater Interfaces. 2014 Sep 24;6(18):15913-24.

  9. Nemani KV, Moodie KL, Brennick JB, Su A, Gimi B. In vitro and in vivo evaluation of SU-8 biocompatibility. Mater Sci Eng C Mater Biol Appl. 2013 Oct;33(7):4453-9.

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