• Title/Summary/Keyword: sterility test

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A Study for Biocompatibility of Acupuncture′s Metal Materials, - Focused on Biological Character - (침 금속재료에 대한 생체적합성 연구 -생물학적 특성을 중심으로-)

  • Baek Yong-Hyeon;Chung In-Tae;Lee Sang-Hoon;Lee Jae-Dong;Choi Do-Young
    • The Journal of Korean Medicine
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    • v.25 no.3
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    • pp.180-190
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    • 2004
  • Objectives : To present criteria for acupuncture standardization, which will improve quality of acupuncture and secure safety, through studies of the biocompatibility of acupuncture materials. Methods : Acupuncture needles distributed in Korea were studied. Intracutaneous reaction tests and sterility tests were executed to study the biocompatibility of acupuncture. Results & Conclusions : All 4 kinds of acupuncture needles distributed in Korea were found suitable for medical use, through intracutaneous reaction tests and sterility tests. However, the medical instrument standards of the Korea Food and Drug Administration lack criteria concerning intracutaneous reaction tests and sterility tests. The criteria for these tests should be standardized in order to secure the biocompatibility of acupuncture needles.

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Analysis of Studies Directed at Elucidating Sterility in Korean Medicine (불임에 관한 국내 한의학 임상연구의 동향 분석)

  • Yang, In Seok;Im, Chae Kwang;Kim, Kwang Joong
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.27 no.1
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    • pp.26-33
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    • 2013
  • The present study explored studies directed at elucidating the effectiveness of Korean medicine in the treatment of sterility and systematically analyzed the trends of studies on sterility. The standardization and objectification based on results for this study may contribute to the development of effective Korean medicine in reducing sterility. In the annual tendency of sterility-related clinical studies, the number of papers began to increase rapidly from 2000, and 15 papers were published from 2000 till 2011. Then, in the technical journals publishing them, The Journal of Oriental Obstetrics & Gynecology published 13 the most papers. In the institutions to which the first authors belonged, Dongguk University Hospital had 5 the most papers. In the number of test subjects was also analyzed and as the result the studies with 1~9 were the most as 10. In the study design analysis, there were 10 case reports, 5 case series and 4 before and after studies. In the analysis of intervention methods, there were 10 papers where only the Korean medicines were given, next 6 papers where the acupuncture and moxibustion were added, and 3 papers where the Korean medical therapies and other subsidiary therapies were used. In the analysis on the existence of pattern identification, there were 12 papers with the pattern identification, 6 without the pattern identification and 1 with the four constitution identification. In the IRB approval, 18 or most papers had not received the IRB approval and just 1 paper got the IRB approval. When the sterility-related clinical studies published in the Korean medical journals were surveyed, it turned out that there are no RCT studies and there is just one study with the IRB approval. And there were 6 papers without the pattern identification of Korean medicine. So, it seems necessary in the future to improve the papers in these respects for the development of Korean medicine sterility treatment with a good basis through the more systematic and accurate study method.

The Importance of Filter Integrity Test to Ensure Sterility of Radiophamaceuticals for Using PET Image

  • Cho, Yong-Hyun;Park, Jun-Hyung;Hwang, Ki-Young;Kim, Hyung-Woo;Lee, Hong-Jae;Kim, Hyun-Ju
    • The Korean Journal of Nuclear Medicine Technology
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    • v.12 no.1
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    • pp.74-77
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    • 2008
  • The radiopharmaceuticals are routinely injected to blood vessel for acquiring PET image. For this reason, It is imperative that they undergo strict quality control measures. Especially, Sterility test is more important than any other quality control procedures. According to the FDA guideline, It requires filter integrity test used in the processing of sterile solutions. Among several methods, we can decide to use bubble point test. We usually use vented GS-filters (Millipore co., USA) which are sterilizinggrade (0.22 um pore size) and are placed upper site on product vial. After the synthesis of $^{18}F$-FDG, solutions wet the membrane in filter and then go into the product vial. By all synthesis steps have finished, we can observe the presence of the bubbles in the product vial. Since we have started this study, we have never found any bubbles in the product vial. Because the maximum pressure intensity of the filter which has set by manufacturer is up to 5 bars, but helium gas pressure is up to 1 bar in our module system. So, we can make 5 bars pressure using helium gas bombe and increase pressure up to 5 bars step by step. However, it does not happen to anything in vial.

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Study on the development of polycaprolacton silica nanohybrid for bone substitutes (폴리카프로락톤 실리카 나노 복합체를 이용한 골이식대체재 개발에 관한 연구)

  • Jung, Keu-sik;Lim, Sung-Bin;Chung, Chin-Hyung;Hong, Ki-Seok;Kim, Jong-Yeo
    • Journal of Periodontal and Implant Science
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    • v.34 no.2
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    • pp.425-448
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    • 2004
  • A bioactive and degradable poly(epsilon -caprolactone)/silica nanohybrid(PSH) was synthesized for the application as a bone substitute. PSH was manufactured by using silica and polycaprolacton. PSH was manufactured in some composition after low crystaline apatite had been formed in simulated body fluid and, was used this study. The safety of the PSH was established by test of acute, and subacute toxicity, sensitization cytotoxicity and sterility. In order to assess activity of osteoblast, the test for attaching osteoblast, proliferation test for osteoblast, differentiating gene expression test are performed in vitro. And bone substitutes were grafted in rabbit's calvarium, during 8 weeks for testing efficacy of bone substitutes. Degree of osteogenesis and absorption of substitutes were evaluated in microscopic level. In result, it was not appeared that acute and subacute toxicity, sensitization in intradermal induction phase, topical induction phase and challenge phase. It was shown that the test can not inhibit cell proliferation. adversely, it had some ability to accelerate cell proliferation. The result of sterility test described bacterial growth was not detected in most test tube. The attaching and proliferation test of osteoblast had good results. In the result of differentiating gene expression test for osteoblast, cbfa1 and, alkaline phosphatase, osteocalcin and GAPDH were detected with mRNA analysis. In the PSH bone formation test, ostgeoblastic activity would be different as material constitution but it had good new bone formation ability except group #218. futhermore, some material had been absorbed within 8 weeks. Above studies, PSH had bio-compatibility with human body, new bone formation ability and accelerate osteoblastic activity. So it would be the efficient bone substitute material with bio-active and biodegradable.

Analysis of Frequencies of Deleterious Chromosomes in On-yang Natural Population of Drosophila melanogaster (언양 자연 집단내 Drosophila melanogaster의 유해 유전자 빈도 분석)

  • 김영필;최영현
    • Journal of Environmental Science International
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    • v.5 no.1
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    • pp.1-6
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    • 1996
  • The genetic variabilities of second chromosomes of Drosophila melanogaster concealed in On-yang natural Population have been analyzed by the Cy/Pm method and an allelism test during two years(1993-1994). The mean frequencies of deleterious(lethal and semilethal) genes in On-yang natural population were estimated to be 23.97% in 1993 and 27.15% in 1994, respectively. The allelism rates between lethal genes in the population were 0.654%(1993) and 1.429%(1994). The mean values of elimination by frequencies of deleterious genes and allelism rates were 0.0004(1993) and 0.0010(1994), respectively. The frequencies of phenotypic sterility of males in 1994 were estimated to be 1.95%, and thoses of genotypic sterility of females and males were estimated to be 1.54% and 2.31%, respectively.

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Hysterosalpingo-contrast sonography: is possible to quantify the therapeutic effect of a diagnostic test?

  • Giugliano, Emilio;Cagnazzo, Elisa;Bazzan, Elisa;Patella, Alfredo;Marci, Roberto
    • Clinical and Experimental Reproductive Medicine
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    • v.39 no.4
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    • pp.161-165
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    • 2012
  • Objective: To evaluate the effect of hysterosalpingo-contrast sonography (HyCoSy) on natural conception in the infertile patient. Methods: We conducted a prospective observational study recruiting 180 patients admitted to Infertility Center of Ferrara University from January 2010 to February 2012. The essential inclusion criteria was the couple's desire to perform only diagnostic evaluation on infertility causes and to wait for natural conception before proceeding with further management. Couples were investigated with hormonal profile, semen analysis and HyCoSy. Expected time for spontaneous pregnancy was 180 days from HyCoSy. First datation sonography of pregnancy was used calculating time elapsed from HyCoSy at conception. Results: Forty patients (22.2%) obtained spontaneous pregnancy within 6 months after HyCoSy. The mean of "conception time" was 75 days. The pregnancy rate was significantly higher in the first 30 days (45%) compared to other the months of observation (p<0.0005). Multiple linear regression analysis showed that maternal age and sterility duration proved independent variables in detecting the "conception time" after HyCoSy (t=3.742, p=0.001, t=2.371, p=0.02, respectively). Conclusion: A possible beneficial effect of HyCoSy is feasible especially in the days following its execution. This temporal correlation supports its therapeutic use.

Cleaning Validation Studies for Multi-Purpose Facility : Vial Filling Machine (다품목 공용 제약설비인 바이알 충전기에 대한 세척공정 밸리데이션)

  • Choi, Han-Gon;Yang, Ho-Joon;Kim, Young-Ran;Sung, Jun-Ho;Hwang, Ma-Ro;Kim, Jong-Oh;Yong, Chul-Soon
    • Journal of Pharmaceutical Investigation
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    • v.39 no.4
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    • pp.263-267
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    • 2009
  • The purpose of this study is to evaluate the efficacy of stipulated cleaning process, and the prohibition of cross-contamination and microbiological contamination, which inadequate cleaning in multi-production could occur, through cleaning validation of multi-purpose facility used to produce five biopharmaceutical products as sterile injection. After production of five biopharmaceutical products such as hGH, rhGCSF, rhEPO, rhFSH and rhIFN using vial filling machine, the cleaning validation such as residual analysis of active ingredients or human serum albumin, measurement of total organic carbon (TOC), residual analysis of detergent and microbiological contamination were carried out. In the case of rhGH and rhGCSF clean validations, drug residues were not detected. Furthermore, in the case of rhEPO, rhFSH and rhIFN clean validations, human serum albumin residues were not detected. At TOC (total organic carbon) analysis, all clean validations gave the TOC of about average 137.93%, not more than 150% of acceptance criteria. At sodium analysis for the checking of residues of cleaning agent, sodium residues were not detected. In sterility test, they showed no microbiological contamination of bacteria and fungi. Thus, this cleaning validation was determined as successful in protection of cross-contamination and induction of safety in multi-purpose facility.

Physiological and Ecological Studies on the Low Temperature Damages of Rice (Oryza sativia L.) (수도의 저온장해에 관한 생리 생태학적 연구)

  • 오윤진
    • KOREAN JOURNAL OF CROP SCIENCE
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    • v.26 no.1
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    • pp.1-31
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    • 1981
  • Experiments were conducted to investigate rice varietal response to low water and air temperatures at different growth stages from 1975 to 1980 in a phytotron in Suweon and in a cold water nursery in Chooncheon. Germination ability, seedling growth, sterility of laspikelets, panicle exertion, discoloration of leaves, and delay of heading of recently developed indica/japonica cross(I/J), japonica, and indica varieties at low air temperature or cold water were compared to those at normal temperature or natural conditions. The results are summarized as follows: 1. Practically acceptable germination rate of 70% was obtained in 10 days after initiation of germination test at 15\circ_C for japonica varieties, but 15 days for IxJ varieties. Varietal differences in germination ability at suboptimal temperature was greatest at 16\circ_C for 6 days. 2. Cold injury of rice seedlings was most severe at the 3.0-and 3.5-leaf stage and it was reduced as growth stage advanced. A significant positive correlation was observed between cold injury at 3-leaf stage and 6-leaf stage. 3. At day/night temperatures of 15/10\circ_C seedlings of both japonica and I/J varieties were dead in 42 days. At 20/15\circ_C japonica varieties produced tillers actively, but tillering of I/J varieties was retarded a little. At 25/15\circ_C, both japonica and I/J varieties produced tillers most actively. Increase in plant height was proportional to the increase in all varieties. 4. In I/J varieties the number of differentiated panicle rachis branches and spikelets was reduced at a day-night temperature of 20-15\circ_C compared to 25-20 or 30-25\circ_C, but not in japonica varieties although panicle exertion was retarded at 20-15\circ_C. The number of spikelets was not correlated with the number of primary rachis branches, but positively correlated with that of secondary rachis branches. 5. Heading of rice varieties treated with 15\circ_C air temperature at meiotic stage was delayed compared to that at tillering stage by 1-3 days and heading was delayed as duration of low temperature treatment increased. 6. At cold water treatment of 17\circ_C from tillering to heading stage, heading of japonica, I/J, and cold tolerant indica varieties was delayed 2-6, 3-9, and 4-5 days, respectively, Growth stage sensitive to delay of heading delay at water treatment were tillering stage, meiotic stage, and booting tage in that order, delay of heading was greater in indica corssed japonica(Suweon 264), japonica(Suweon 235), and cold tolerant indica(Lengkwang) varieties in that order. Delay of heading due to cold water treatment was positively correlated with culm length reduction and spikelet sterility. 7. Elongation of culms and exertion of panicles of rice varieties treated with low air temperature 17\circ_C. Culm length reduction rate of tall varieties was lower than that of short statured varieties at low temperature. Panicle exertion was most severaly retarded with low temperature treatment at heading stage. Generally, retardation of panicle exertion of 1/1 varieties was more severe than that of japonica varieties at low temperature. There was a positive correlation between panicle exertion and culm length at low temperature. 8. The number of panicles was increased with cold water treatment at tillering stage, but reduced at meiotic stage. As time of cold water treatment was conducted at earlier growth stage, culm length was shorter and panicle exertion poorer. 9. Sterility of all rice varieties was negligible at 17\circ_C for three days but 30.3-85.2% of strility was observed for nine-day treatment at 17\circ_C. Among the tested varieties, sterility of Suweon 264 and Milyang 42 was highest and that of Suweon 290 and Suweon 287 was lowest. The most sensitive growth stage to low temperature induced sterility was from 15 to 5 days before heading. There was positive correlation between sterility of rice plants treated with low temperature at meiotic and heading stage. 10. Percentage of spikelet sterility was greatest at cold water treatment at meiotic stage (auricle distance -15~-10cm) and it was higher in 1/1 (Suweon 264, Joseng tongil), japonica (Nongbaek, Towada), and cold tolerance indica(Lengkwang) varieties in the order. Level of cold water and position of young-ear affected on the sterility of varieties at meiotic stage; percentage of spikelet sterility of variety, Lengkwang, of which young-ear was located above the cold water level was high, but that of short statured variety, Suweon 264, of which young-ear was located in the cold water was lower. 11. Percentage of ripened grains was not reducted at 15\circ_C air temperature for three days at full heading stage in all varieties. However, at six-day low temperature treatment Suweon 287, Suweon 264 showed percentage of ripended grains lower than 60%, but at nine-day low temperature treatment all varieties showed percentage of ripened grains lower than 60%. Low temperature treatment of 17\circ_C from 10 days after heading for 20 days did not affect on the ripening of all varieties. 12. Uptake of nitrogen, phosphorous, potassium, calcium, and magnesium in whole plants was higher at average air temperature of 25\circ_C, but concentration of the elements was lower compared to those at 19\circ_C. However, both total uptake and concentration of manganese were higher at 19\circ_C compared to 25\circ_C. 13. Higher application of nitrogen, phosphorus, silicate, and compost increased yield of rice due to increased number of panicles and spike let fertility in cold water irrigated paddy.

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Evaluation for foot-and-mouth disease vaccines in South Korea by the test for national lot release (구제역 백신의 국가출하승인검정을 통한 품질 평가)

  • Kim, Mun-Hyeon;Seo, Min-Goo;Lee, Hyang-Sim;Kim, Ji-Yeon;Kim, Ji-Ye;Kim, Yong-Sang;Kim, Yeon-Hee
    • Korean Journal of Veterinary Service
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    • v.42 no.4
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    • pp.285-288
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    • 2019
  • Foot-and-mouth disease (FMD) causes economic problems in livestock industry because of fast spread and inducing low productivity. FMD outbreaks occurred in South Korea over the period from 2000 to 2019. Vaccination is the most practical and effective means of controlling or preventing these outbreaks, and a national vaccination policy has been in place for all FMD-susceptible animals since 2010. To prevent and control of FMD, South Korea has been using vaccines imported from the United Kingdom, Argentina, and Russia. The Animal and Plant Quarantine Agency of South Korea oversees continuous quality control of imported FMD vaccines. FMD vaccines were evaluated characteristics, sterility, pH, inactivation, safety, potency test by Korean FMD vaccine standard assay (Test for National Lot Release). The 6 company vaccines (A~F) were used Test for National Lot Release by each method. We evaluated quality of each FMD vaccine from 2015 to 2019. All batch of vaccine showed good quality control and were passed the Test for National Lot Release. The serotypes of vaccine are increasingly changing to multiple vaccine because the FMD was outbreak by various serotype virus in South Korea. Furthermore, this data may be useful as a basis for ensuring the quality of FMD vaccines and for base data to manage them. Additional study is required to simple approach for rapid evaluation of quality and antigen content identification in vaccines.

The effects of exposure at room temperature to pharmacopuncture within a syringe : an investigation of changes in microbiological safety (Syringe에 재어 놓은 약침의 시간에 따른 미생물학적 안전성 연구)

  • Lee, Chong Hwan;Lee, Jin Ho;Ha, In Hyuk;Kim, Me Riong;Lee, In Hee;Lee, Jae Woong;Kim, Eun Jee;Kim, Hae Sol;Kim, Ho Sun;Bae, Young Hyeon;Kim, No Hyeon;Suh, Chang Yong;Byun, Jang Hoon;Park, Sang Won;Kim, Min Jeong
    • Journal of Acupuncture Research
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    • v.32 no.4
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    • pp.37-45
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    • 2015
  • Objectives : The main aim of this study is to evaluate changes in the microbiological safety of pharmacopuncture exposed to room temperature for an elapsed period of time. Methods : The four most frequently used pharmacopuncture products were stored in syringes at room temperature at three different hospitals for 24 hours and 48 hours respectively, and they were compared with pharmacopuncture products stored in vials through a sterility and microbial limited test. Results : Storage forms and duration of exposure to room temperature did not show significant difference in bacterial or fungal contamination, which was confirmed by the sterility and microbial limited test. Conclusions : Pharmacopuncture products stored in syringes at room temperature for 24 hours and 48 hours demonstrated their safety in terms of lack of microbiological contamination.