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上海檢測標準YBB00212004-2015

發布時間:2024-05-10 17:52:50   來源:廣西藝景園林工程有限責任公司   閱覽次數:3325次   

藥(yao)(yao)(yao)(yao)品(pin)(pin)(pin)包(bao)(bao)(bao)(bao)裝(zhuang)(zhuang)(zhuang)(zhuang)材(cai)(cai)料(liao)(liao)(liao)的(de)(de)(de)(de)(de)主要(yao)功能是什么(me)?1.保護藥(yao)(yao)(yao)(yao)品(pin)(pin)(pin)質量(liang)(liang):藥(yao)(yao)(yao)(yao)品(pin)(pin)(pin)包(bao)(bao)(bao)(bao)裝(zhuang)(zhuang)(zhuang)(zhuang)材(cai)(cai)料(liao)(liao)(liao)可以(yi)防止(zhi)(zhi)外(wai)界因(yin)素(su)對藥(yao)(yao)(yao)(yao)品(pin)(pin)(pin)的(de)(de)(de)(de)(de)影(ying)響,如(ru)光(guang)線、濕氣、氧(yang)氣和(he)(he)(he)微生(sheng)物(wu)。藥(yao)(yao)(yao)(yao)品(pin)(pin)(pin)容易(yi)受(shou)到這(zhe)些因(yin)素(su)的(de)(de)(de)(de)(de)污(wu)染和(he)(he)(he)降解,因(yin)此包(bao)(bao)(bao)(bao)裝(zhuang)(zhuang)(zhuang)(zhuang)材(cai)(cai)料(liao)(liao)(liao)必須具有(you)良好(hao)的(de)(de)(de)(de)(de)防護性(xing)能,確(que)保藥(yao)(yao)(yao)(yao)品(pin)(pin)(pin)的(de)(de)(de)(de)(de)質量(liang)(liang)和(he)(he)(he)有(you)效性(xing)。2.防止(zhi)(zhi)藥(yao)(yao)(yao)(yao)品(pin)(pin)(pin)泄(xie)漏(lou):藥(yao)(yao)(yao)(yao)品(pin)(pin)(pin)包(bao)(bao)(bao)(bao)裝(zhuang)(zhuang)(zhuang)(zhuang)材(cai)(cai)料(liao)(liao)(liao)必須具有(you)良好(hao)的(de)(de)(de)(de)(de)密封性(xing)能,以(yi)防止(zhi)(zhi)藥(yao)(yao)(yao)(yao)品(pin)(pin)(pin)泄(xie)漏(lou)。藥(yao)(yao)(yao)(yao)品(pin)(pin)(pin)的(de)(de)(de)(de)(de)泄(xie)漏(lou)不(bu)僅會導致藥(yao)(yao)(yao)(yao)品(pin)(pin)(pin)的(de)(de)(de)(de)(de)浪(lang)費,還(huan)可能對使用(yong)者(zhe)(zhe)(zhe)造成傷害。因(yin)此,包(bao)(bao)(bao)(bao)裝(zhuang)(zhuang)(zhuang)(zhuang)材(cai)(cai)料(liao)(liao)(liao)必須能夠有(you)效地保持藥(yao)(yao)(yao)(yao)品(pin)(pin)(pin)的(de)(de)(de)(de)(de)完整性(xing)和(he)(he)(he)安全性(xing)。3.提供(gong)(gong)正(zheng)(zheng)確(que)的(de)(de)(de)(de)(de)劑(ji)(ji)(ji)量(liang)(liang):藥(yao)(yao)(yao)(yao)品(pin)(pin)(pin)包(bao)(bao)(bao)(bao)裝(zhuang)(zhuang)(zhuang)(zhuang)材(cai)(cai)料(liao)(liao)(liao)通常包(bao)(bao)(bao)(bao)括劑(ji)(ji)(ji)量(liang)(liang)器(qi),如(ru)滴管(guan)、匙匙或注(zhu)射器(qi)。這(zhe)些劑(ji)(ji)(ji)量(liang)(liang)器(qi)可以(yi)確(que)保患(huan)者(zhe)(zhe)(zhe)正(zheng)(zheng)確(que)使用(yong)藥(yao)(yao)(yao)(yao)品(pin)(pin)(pin),并避免(mian)劑(ji)(ji)(ji)量(liang)(liang)錯誤。正(zheng)(zheng)確(que)的(de)(de)(de)(de)(de)劑(ji)(ji)(ji)量(liang)(liang)對于藥(yao)(yao)(yao)(yao)物(wu)療效的(de)(de)(de)(de)(de)發揮至關(guan)重(zhong)要(yao),因(yin)此包(bao)(bao)(bao)(bao)裝(zhuang)(zhuang)(zhuang)(zhuang)材(cai)(cai)料(liao)(liao)(liao)必須能夠提供(gong)(gong)準確(que)和(he)(he)(he)方(fang)(fang)便的(de)(de)(de)(de)(de)劑(ji)(ji)(ji)量(liang)(liang)器(qi)。4.提供(gong)(gong)信(xin)息(xi)和(he)(he)(he)警示(shi):藥(yao)(yao)(yao)(yao)品(pin)(pin)(pin)包(bao)(bao)(bao)(bao)裝(zhuang)(zhuang)(zhuang)(zhuang)材(cai)(cai)料(liao)(liao)(liao)上通常印有(you)藥(yao)(yao)(yao)(yao)品(pin)(pin)(pin)的(de)(de)(de)(de)(de)名稱、用(yong)途、劑(ji)(ji)(ji)量(liang)(liang)、使用(yong)方(fang)(fang)法和(he)(he)(he)注(zhu)意(yi)事項等重(zhong)要(yao)信(xin)息(xi)。這(zhe)些信(xin)息(xi)對于患(huan)者(zhe)(zhe)(zhe)正(zheng)(zheng)確(que)使用(yong)藥(yao)(yao)(yao)(yao)品(pin)(pin)(pin)和(he)(he)(he)避免(mian)不(bu)良反應至關(guan)重(zhong)要(yao)。此外(wai),包(bao)(bao)(bao)(bao)裝(zhuang)(zhuang)(zhuang)(zhuang)材(cai)(cai)料(liao)(liao)(liao)還(huan)可以(yi)印有(you)警示(shi)標(biao)志,提醒患(huan)者(zhe)(zhe)(zhe)注(zhu)意(yi)藥(yao)(yao)(yao)(yao)品(pin)(pin)(pin)的(de)(de)(de)(de)(de)特殊要(yao)求或潛在(zai)風(feng)險(xian)。醫藥(yao)(yao)(yao)(yao)包(bao)(bao)(bao)(bao)裝(zhuang)(zhuang)(zhuang)(zhuang)材(cai)(cai)料(liao)(liao)(liao)檢(jian)測(ce)可以(yi)檢(jian)測(ce)材(cai)(cai)料(liao)(liao)(liao)中的(de)(de)(de)(de)(de)有(you)害物(wu)質,如(ru)重(zhong)金(jin)屬、有(you)機溶劑(ji)(ji)(ji)等,保證藥(yao)(yao)(yao)(yao)品(pin)(pin)(pin)不(bu)會受(shou)到污(wu)染。上海檢(jian)測(ce)標(biao)準YBB00212004-2015

上海檢測標準YBB00212004-2015,藥品包裝材料

醫藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)包(bao)(bao)(bao)(bao)(bao)裝(zhuang)(zhuang)(zhuang)材(cai)(cai)(cai)料(liao)檢(jian)測(ce)(ce)的(de)(de)(de)(de)(de)(de)重要(yao)性(xing)(xing)是什么(me)?1.保(bao)(bao)(bao)(bao)障藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)的(de)(de)(de)(de)(de)(de)質(zhi)量(liang)(liang)和(he)安(an)全(quan)(quan)性(xing)(xing)能:醫藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)包(bao)(bao)(bao)(bao)(bao)裝(zhuang)(zhuang)(zhuang)材(cai)(cai)(cai)料(liao)的(de)(de)(de)(de)(de)(de)質(zhi)量(liang)(liang)直(zhi)接影(ying)響藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)的(de)(de)(de)(de)(de)(de)質(zhi)量(liang)(liang)和(he)安(an)全(quan)(quan)性(xing)(xing)。不合格(ge)(ge)的(de)(de)(de)(de)(de)(de)包(bao)(bao)(bao)(bao)(bao)裝(zhuang)(zhuang)(zhuang)材(cai)(cai)(cai)料(liao)可能會(hui)導致藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)的(de)(de)(de)(de)(de)(de)變質(zhi)、降解或污(wu)染(ran)(ran),從(cong)(cong)而(er)(er)影(ying)響藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)的(de)(de)(de)(de)(de)(de)療效和(he)安(an)全(quan)(quan)性(xing)(xing)。通(tong)過(guo)對(dui)(dui)包(bao)(bao)(bao)(bao)(bao)裝(zhuang)(zhuang)(zhuang)材(cai)(cai)(cai)料(liao)進(jin)行檢(jian)測(ce)(ce),可以確(que)保(bao)(bao)(bao)(bao)其(qi)符合相(xiang)關(guan)的(de)(de)(de)(de)(de)(de)質(zhi)量(liang)(liang)標(biao)準(zhun),從(cong)(cong)而(er)(er)保(bao)(bao)(bao)(bao)障藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)的(de)(de)(de)(de)(de)(de)質(zhi)量(liang)(liang)和(he)安(an)全(quan)(quan)性(xing)(xing)。2.防(fang)(fang)止(zhi)藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)的(de)(de)(de)(de)(de)(de)外界(jie)污(wu)染(ran)(ran):醫藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)包(bao)(bao)(bao)(bao)(bao)裝(zhuang)(zhuang)(zhuang)材(cai)(cai)(cai)料(liao)在藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)運輸和(he)儲存過(guo)程(cheng)中起到了保(bao)(bao)(bao)(bao)護藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)的(de)(de)(de)(de)(de)(de)作用(yong)。合格(ge)(ge)的(de)(de)(de)(de)(de)(de)包(bao)(bao)(bao)(bao)(bao)裝(zhuang)(zhuang)(zhuang)材(cai)(cai)(cai)料(liao)應(ying)具有良好(hao)的(de)(de)(de)(de)(de)(de)密封性(xing)(xing)和(he)防(fang)(fang)潮性(xing)(xing),以防(fang)(fang)止(zhi)藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)受(shou)到外界(jie)污(wu)染(ran)(ran)。通(tong)過(guo)對(dui)(dui)包(bao)(bao)(bao)(bao)(bao)裝(zhuang)(zhuang)(zhuang)材(cai)(cai)(cai)料(liao)進(jin)行檢(jian)測(ce)(ce),可以確(que)保(bao)(bao)(bao)(bao)其(qi)具備良好(hao)的(de)(de)(de)(de)(de)(de)密封性(xing)(xing)和(he)防(fang)(fang)潮性(xing)(xing),有效地防(fang)(fang)止(zhi)藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)受(shou)到外界(jie)污(wu)染(ran)(ran)。3.提高藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)的(de)(de)(de)(de)(de)(de)穩(wen)定(ding)性(xing)(xing)能:藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)的(de)(de)(de)(de)(de)(de)穩(wen)定(ding)性(xing)(xing)對(dui)(dui)于(yu)其(qi)有效性(xing)(xing)和(he)安(an)全(quan)(quan)性(xing)(xing)至關(guan)重要(yao)。不合格(ge)(ge)的(de)(de)(de)(de)(de)(de)包(bao)(bao)(bao)(bao)(bao)裝(zhuang)(zhuang)(zhuang)材(cai)(cai)(cai)料(liao)可能會(hui)導致藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)的(de)(de)(de)(de)(de)(de)氧化、光敏(min)性(xing)(xing)或水解等問題(ti),從(cong)(cong)而(er)(er)降低藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)的(de)(de)(de)(de)(de)(de)穩(wen)定(ding)性(xing)(xing)。通(tong)過(guo)對(dui)(dui)包(bao)(bao)(bao)(bao)(bao)裝(zhuang)(zhuang)(zhuang)材(cai)(cai)(cai)料(liao)進(jin)行檢(jian)測(ce)(ce),可以確(que)保(bao)(bao)(bao)(bao)其(qi)對(dui)(dui)藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)具有良好(hao)的(de)(de)(de)(de)(de)(de)保(bao)(bao)(bao)(bao)護性(xing)(xing),提高藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)的(de)(de)(de)(de)(de)(de)穩(wen)定(ding)性(xing)(xing)。4.保(bao)(bao)(bao)(bao)護患者的(de)(de)(de)(de)(de)(de)健(jian)(jian)康(kang):醫藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)包(bao)(bao)(bao)(bao)(bao)裝(zhuang)(zhuang)(zhuang)材(cai)(cai)(cai)料(liao)的(de)(de)(de)(de)(de)(de)質(zhi)量(liang)(liang)和(he)安(an)全(quan)(quan)性(xing)(xing)直(zhi)接關(guan)系到患者的(de)(de)(de)(de)(de)(de)健(jian)(jian)康(kang)。合格(ge)(ge)的(de)(de)(de)(de)(de)(de)包(bao)(bao)(bao)(bao)(bao)裝(zhuang)(zhuang)(zhuang)材(cai)(cai)(cai)料(liao)可以保(bao)(bao)(bao)(bao)護藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)的(de)(de)(de)(de)(de)(de)質(zhi)量(liang)(liang)和(he)安(an)全(quan)(quan)性(xing)(xing),從(cong)(cong)而(er)(er)確(que)保(bao)(bao)(bao)(bao)患者在使用(yong)藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)時不會(hui)受(shou)到傷害(hai)。通(tong)過(guo)對(dui)(dui)包(bao)(bao)(bao)(bao)(bao)裝(zhuang)(zhuang)(zhuang)材(cai)(cai)(cai)料(liao)進(jin)行檢(jian)測(ce)(ce),可以較大(da)程(cheng)度地保(bao)(bao)(bao)(bao)護患者的(de)(de)(de)(de)(de)(de)健(jian)(jian)康(kang)。上海檢(jian)測(ce)(ce)標(biao)準(zhun)YBB00212004-2015包(bao)(bao)(bao)(bao)(bao)裝(zhuang)(zhuang)(zhuang)材(cai)(cai)(cai)料(liao)應(ying)具有良好(hao)的(de)(de)(de)(de)(de)(de)耐(nai)溫性(xing)(xing),能夠承受(shou)藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)的(de)(de)(de)(de)(de)(de)加(jia)熱或冷凍處理。

上海檢測標準YBB00212004-2015,藥品包裝材料

藥品包(bao)(bao)材(cai)(cai)(cai)溶(rong)(rong)(rong)(rong)(rong)劑(ji)(ji)殘(can)(can)留(liu)(liu)(liu)(liu)檢(jian)(jian)測(ce)的(de)(de)(de)影(ying)響(xiang)(xiang)因(yin)(yin)(yin)素(su)(su)有哪些?1.包(bao)(bao)材(cai)(cai)(cai)材(cai)(cai)(cai)質:藥品包(bao)(bao)材(cai)(cai)(cai)的(de)(de)(de)材(cai)(cai)(cai)質是(shi)影(ying)響(xiang)(xiang)溶(rong)(rong)(rong)(rong)(rong)劑(ji)(ji)殘(can)(can)留(liu)(liu)(liu)(liu)的(de)(de)(de)重(zhong)(zhong)(zhong)要(yao)(yao)(yao)(yao)因(yin)(yin)(yin)素(su)(su)之一。不(bu)同(tong)材(cai)(cai)(cai)質的(de)(de)(de)包(bao)(bao)材(cai)(cai)(cai)在(zai)制造(zao)過程(cheng)中(zhong)可(ke)能(neng)使用不(bu)同(tong)的(de)(de)(de)溶(rong)(rong)(rong)(rong)(rong)劑(ji)(ji),這(zhe)些溶(rong)(rong)(rong)(rong)(rong)劑(ji)(ji)可(ke)能(neng)會殘(can)(can)留(liu)(liu)(liu)(liu)在(zai)包(bao)(bao)材(cai)(cai)(cai)中(zhong)。因(yin)(yin)(yin)此(ci),選(xuan)擇合(he)(he)適(shi)的(de)(de)(de)包(bao)(bao)材(cai)(cai)(cai)材(cai)(cai)(cai)質對(dui)(dui)于減少(shao)溶(rong)(rong)(rong)(rong)(rong)劑(ji)(ji)殘(can)(can)留(liu)(liu)(liu)(liu)至關重(zhong)(zhong)(zhong)要(yao)(yao)(yao)(yao)。2.包(bao)(bao)材(cai)(cai)(cai)制造(zao)工(gong)藝:包(bao)(bao)材(cai)(cai)(cai)的(de)(de)(de)制造(zao)工(gong)藝也(ye)會對(dui)(dui)溶(rong)(rong)(rong)(rong)(rong)劑(ji)(ji)殘(can)(can)留(liu)(liu)(liu)(liu)產生(sheng)影(ying)響(xiang)(xiang)。制造(zao)過程(cheng)中(zhong)使用的(de)(de)(de)溶(rong)(rong)(rong)(rong)(rong)劑(ji)(ji)種(zhong)類、溶(rong)(rong)(rong)(rong)(rong)劑(ji)(ji)的(de)(de)(de)純度以及制造(zao)工(gong)藝的(de)(de)(de)控制都會影(ying)響(xiang)(xiang)溶(rong)(rong)(rong)(rong)(rong)劑(ji)(ji)殘(can)(can)留(liu)(liu)(liu)(liu)的(de)(de)(de)水(shui)(shui)(shui)(shui)平(ping)。因(yin)(yin)(yin)此(ci),嚴格(ge)控制包(bao)(bao)材(cai)(cai)(cai)的(de)(de)(de)制造(zao)工(gong)藝是(shi)減少(shao)溶(rong)(rong)(rong)(rong)(rong)劑(ji)(ji)殘(can)(can)留(liu)(liu)(liu)(liu)的(de)(de)(de)重(zhong)(zhong)(zhong)要(yao)(yao)(yao)(yao)手段。3.包(bao)(bao)材(cai)(cai)(cai)存儲(chu)條件:包(bao)(bao)材(cai)(cai)(cai)在(zai)存儲(chu)過程(cheng)中(zhong)可(ke)能(neng)會受到溫度、濕度等環境因(yin)(yin)(yin)素(su)(su)的(de)(de)(de)影(ying)響(xiang)(xiang)。這(zhe)些因(yin)(yin)(yin)素(su)(su)可(ke)能(neng)導致包(bao)(bao)材(cai)(cai)(cai)中(zhong)溶(rong)(rong)(rong)(rong)(rong)劑(ji)(ji)的(de)(de)(de)揮發或溶(rong)(rong)(rong)(rong)(rong)劑(ji)(ji)的(de)(de)(de)吸附(fu),從(cong)而影(ying)響(xiang)(xiang)溶(rong)(rong)(rong)(rong)(rong)劑(ji)(ji)殘(can)(can)留(liu)(liu)(liu)(liu)的(de)(de)(de)水(shui)(shui)(shui)(shui)平(ping)。因(yin)(yin)(yin)此(ci),合(he)(he)理(li)的(de)(de)(de)包(bao)(bao)材(cai)(cai)(cai)存儲(chu)條件對(dui)(dui)于保持包(bao)(bao)材(cai)(cai)(cai)中(zhong)溶(rong)(rong)(rong)(rong)(rong)劑(ji)(ji)殘(can)(can)留(liu)(liu)(liu)(liu)的(de)(de)(de)穩定(ding)性至關重(zhong)(zhong)(zhong)要(yao)(yao)(yao)(yao)。4.檢(jian)(jian)測(ce)方(fang)法和(he)設(she)備:溶(rong)(rong)(rong)(rong)(rong)劑(ji)(ji)殘(can)(can)留(liu)(liu)(liu)(liu)的(de)(de)(de)檢(jian)(jian)測(ce)方(fang)法和(he)設(she)備也(ye)會對(dui)(dui)檢(jian)(jian)測(ce)結果產生(sheng)影(ying)響(xiang)(xiang)。不(bu)同(tong)的(de)(de)(de)檢(jian)(jian)測(ce)方(fang)法可(ke)能(neng)對(dui)(dui)不(bu)同(tong)類型的(de)(de)(de)溶(rong)(rong)(rong)(rong)(rong)劑(ji)(ji)具有不(bu)同(tong)的(de)(de)(de)靈敏度和(he)選(xuan)擇性。因(yin)(yin)(yin)此(ci),選(xuan)擇合(he)(he)適(shi)的(de)(de)(de)檢(jian)(jian)測(ce)方(fang)法和(he)設(she)備對(dui)(dui)于準(zhun)(zhun)確(que)檢(jian)(jian)測(ce)溶(rong)(rong)(rong)(rong)(rong)劑(ji)(ji)殘(can)(can)留(liu)(liu)(liu)(liu)水(shui)(shui)(shui)(shui)平(ping)至關重(zhong)(zhong)(zhong)要(yao)(yao)(yao)(yao)。5.檢(jian)(jian)測(ce)標(biao)準(zhun)(zhun):溶(rong)(rong)(rong)(rong)(rong)劑(ji)(ji)殘(can)(can)留(liu)(liu)(liu)(liu)的(de)(de)(de)檢(jian)(jian)測(ce)標(biao)準(zhun)(zhun)是(shi)評估溶(rong)(rong)(rong)(rong)(rong)劑(ji)(ji)殘(can)(can)留(liu)(liu)(liu)(liu)水(shui)(shui)(shui)(shui)平(ping)是(shi)否符合(he)(he)要(yao)(yao)(yao)(yao)求的(de)(de)(de)依據。不(bu)同(tong)的(de)(de)(de)藥品可(ke)能(neng)有不(bu)同(tong)的(de)(de)(de)溶(rong)(rong)(rong)(rong)(rong)劑(ji)(ji)殘(can)(can)留(liu)(liu)(liu)(liu)限量要(yao)(yao)(yao)(yao)求。因(yin)(yin)(yin)此(ci),制定(ding)合(he)(he)理(li)的(de)(de)(de)檢(jian)(jian)測(ce)標(biao)準(zhun)(zhun)對(dui)(dui)于準(zhun)(zhun)確(que)評估溶(rong)(rong)(rong)(rong)(rong)劑(ji)(ji)殘(can)(can)留(liu)(liu)(liu)(liu)水(shui)(shui)(shui)(shui)平(ping)至關重(zhong)(zhong)(zhong)要(yao)(yao)(yao)(yao)。

藥(yao)品(pin)(pin)包(bao)(bao)裝(zhuang)(zhuang)材(cai)(cai)(cai)(cai)(cai)料(liao)(liao)的(de)(de)(de)(de)密(mi)(mi)(mi)封(feng)(feng)(feng)(feng)(feng)性(xing)(xing)(xing)(xing)能(neng)主要取決于(yu)以(yi)下幾個(ge)方面:1.材(cai)(cai)(cai)(cai)(cai)料(liao)(liao)選擇(ze):藥(yao)品(pin)(pin)包(bao)(bao)裝(zhuang)(zhuang)材(cai)(cai)(cai)(cai)(cai)料(liao)(liao)通(tong)(tong)常(chang)(chang)采用塑(su)(su)料(liao)(liao)、玻璃(li)、鋁箔(bo)等(deng)材(cai)(cai)(cai)(cai)(cai)料(liao)(liao)。不(bu)(bu)同材(cai)(cai)(cai)(cai)(cai)料(liao)(liao)具(ju)(ju)有不(bu)(bu)同的(de)(de)(de)(de)密(mi)(mi)(mi)封(feng)(feng)(feng)(feng)(feng)性(xing)(xing)(xing)(xing)能(neng)。例如(ru),鋁箔(bo)具(ju)(ju)有良好的(de)(de)(de)(de)阻隔性(xing)(xing)(xing)(xing)能(neng),能(neng)夠有效地防(fang)止氧氣和(he)(he)水分的(de)(de)(de)(de)滲透,而塑(su)(su)料(liao)(liao)材(cai)(cai)(cai)(cai)(cai)料(liao)(liao)則可以(yi)提供更(geng)好的(de)(de)(de)(de)柔性(xing)(xing)(xing)(xing)和(he)(he)可塑(su)(su)性(xing)(xing)(xing)(xing)。2.密(mi)(mi)(mi)封(feng)(feng)(feng)(feng)(feng)方式(shi):藥(yao)品(pin)(pin)包(bao)(bao)裝(zhuang)(zhuang)通(tong)(tong)常(chang)(chang)采用熱(re)(re)封(feng)(feng)(feng)(feng)(feng)、冷(leng)封(feng)(feng)(feng)(feng)(feng)、膠(jiao)封(feng)(feng)(feng)(feng)(feng)等(deng)方式(shi)進(jin)行密(mi)(mi)(mi)封(feng)(feng)(feng)(feng)(feng)。熱(re)(re)封(feng)(feng)(feng)(feng)(feng)是(shi)常(chang)(chang)見的(de)(de)(de)(de)一(yi)種方式(shi),通(tong)(tong)過加熱(re)(re)使包(bao)(bao)裝(zhuang)(zhuang)材(cai)(cai)(cai)(cai)(cai)料(liao)(liao)的(de)(de)(de)(de)兩層(ceng)(ceng)(ceng)(ceng)或(huo)多(duo)層(ceng)(ceng)(ceng)(ceng)相(xiang)互粘(zhan)合,形成(cheng)密(mi)(mi)(mi)封(feng)(feng)(feng)(feng)(feng)。冷(leng)封(feng)(feng)(feng)(feng)(feng)則是(shi)利用冷(leng)壓力將包(bao)(bao)裝(zhuang)(zhuang)材(cai)(cai)(cai)(cai)(cai)料(liao)(liao)粘(zhan)合在(zai)一(yi)起(qi)。膠(jiao)封(feng)(feng)(feng)(feng)(feng)則是(shi)使用膠(jiao)水或(huo)膠(jiao)帶將包(bao)(bao)裝(zhuang)(zhuang)材(cai)(cai)(cai)(cai)(cai)料(liao)(liao)粘(zhan)合在(zai)一(yi)起(qi)。不(bu)(bu)同的(de)(de)(de)(de)密(mi)(mi)(mi)封(feng)(feng)(feng)(feng)(feng)方式(shi)對(dui)密(mi)(mi)(mi)封(feng)(feng)(feng)(feng)(feng)性(xing)(xing)(xing)(xing)能(neng)有不(bu)(bu)同的(de)(de)(de)(de)影響,需要根據具(ju)(ju)體藥(yao)品(pin)(pin)的(de)(de)(de)(de)特性(xing)(xing)(xing)(xing)和(he)(he)要求進(jin)行選擇(ze)。3.包(bao)(bao)裝(zhuang)(zhuang)結構:藥(yao)品(pin)(pin)包(bao)(bao)裝(zhuang)(zhuang)通(tong)(tong)常(chang)(chang)采用多(duo)層(ceng)(ceng)(ceng)(ceng)結構,包(bao)(bao)括內層(ceng)(ceng)(ceng)(ceng)、中(zhong)(zhong)(zhong)層(ceng)(ceng)(ceng)(ceng)和(he)(he)外層(ceng)(ceng)(ceng)(ceng)。內層(ceng)(ceng)(ceng)(ceng)通(tong)(tong)常(chang)(chang)是(shi)直接(jie)接(jie)觸(chu)藥(yao)品(pin)(pin)的(de)(de)(de)(de)層(ceng)(ceng)(ceng)(ceng),需要具(ju)(ju)備良好的(de)(de)(de)(de)密(mi)(mi)(mi)封(feng)(feng)(feng)(feng)(feng)性(xing)(xing)(xing)(xing)能(neng),以(yi)防(fang)止藥(yao)品(pin)(pin)與外界環境的(de)(de)(de)(de)接(jie)觸(chu)。中(zhong)(zhong)(zhong)層(ceng)(ceng)(ceng)(ceng)通(tong)(tong)常(chang)(chang)是(shi)增強包(bao)(bao)裝(zhuang)(zhuang)材(cai)(cai)(cai)(cai)(cai)料(liao)(liao)的(de)(de)(de)(de)強度和(he)(he)穩定性(xing)(xing)(xing)(xing),外層(ceng)(ceng)(ceng)(ceng)則是(shi)保(bao)護(hu)內層(ceng)(ceng)(ceng)(ceng)和(he)(he)中(zhong)(zhong)(zhong)層(ceng)(ceng)(ceng)(ceng),防(fang)止外界因素對(dui)藥(yao)品(pin)(pin)的(de)(de)(de)(de)影響。不(bu)(bu)同層(ceng)(ceng)(ceng)(ceng)次的(de)(de)(de)(de)結構可以(yi)提供更(geng)好的(de)(de)(de)(de)密(mi)(mi)(mi)封(feng)(feng)(feng)(feng)(feng)性(xing)(xing)(xing)(xing)能(neng)和(he)(he)保(bao)護(hu)性(xing)(xing)(xing)(xing)能(neng)。藥(yao)品(pin)(pin)包(bao)(bao)材(cai)(cai)(cai)(cai)(cai)溶(rong)劑殘留檢(jian)測可以(yi)幫助制藥(yao)企業(ye)降低生產成(cheng)本,避免因包(bao)(bao)材(cai)(cai)(cai)(cai)(cai)質量問題而造成(cheng)的(de)(de)(de)(de)損失。

上海檢測標準YBB00212004-2015,藥品包裝材料

藥品(pin)(pin)包(bao)材溶(rong)(rong)劑殘(can)(can)(can)留(liu)檢測(ce)的(de)(de)樣(yang)(yang)品(pin)(pin)采(cai)集方(fang)法(fa)(fa)(fa)(fa)有哪些?一(yi)、直(zhi)接(jie)抽取(qu)法(fa)(fa)(fa)(fa):直(zhi)接(jie)抽取(qu)法(fa)(fa)(fa)(fa)是(shi)(shi)常用(yong)的(de)(de)樣(yang)(yang)品(pin)(pin)采(cai)集方(fang)法(fa)(fa)(fa)(fa)之一(yi)。該方(fang)法(fa)(fa)(fa)(fa)適(shi)用(yong)于(yu)包(bao)材表面的(de)(de)溶(rong)(rong)劑殘(can)(can)(can)留(liu)檢測(ce),具(ju)體(ti)操作(zuo)步(bu)驟如(ru)(ru)下:1.準備(bei)好需要檢測(ce)的(de)(de)包(bao)材樣(yang)(yang)品(pin)(pin);2.使用(yong)合適(shi)的(de)(de)溶(rong)(rong)劑(如(ru)(ru)乙醇、甲醇等(deng))將(jiang)(jiang)包(bao)材表面的(de)(de)溶(rong)(rong)劑殘(can)(can)(can)留(liu)物(wu)溶(rong)(rong)解;3.使用(yong)適(shi)當的(de)(de)儀器(qi)(qi)(如(ru)(ru)氣相色(se)(se)譜儀)對(dui)溶(rong)(rong)解液進行分析,檢測(ce)溶(rong)(rong)劑殘(can)(can)(can)留(liu)物(wu)的(de)(de)含量。二(er)、吸附(fu)(fu)法(fa)(fa)(fa)(fa):吸附(fu)(fu)法(fa)(fa)(fa)(fa)是(shi)(shi)一(yi)種常用(yong)的(de)(de)樣(yang)(yang)品(pin)(pin)采(cai)集方(fang)法(fa)(fa)(fa)(fa),適(shi)用(yong)于(yu)包(bao)材內部的(de)(de)溶(rong)(rong)劑殘(can)(can)(can)留(liu)檢測(ce)。具(ju)體(ti)操作(zuo)步(bu)驟如(ru)(ru)下:1.準備(bei)好需要檢測(ce)的(de)(de)包(bao)材樣(yang)(yang)品(pin)(pin);2.將(jiang)(jiang)包(bao)材樣(yang)(yang)品(pin)(pin)切割(ge)成適(shi)當大小的(de)(de)塊狀;3.將(jiang)(jiang)包(bao)材樣(yang)(yang)品(pin)(pin)放入(ru)密封(feng)的(de)(de)容器(qi)(qi)中,加入(ru)適(shi)量的(de)(de)吸附(fu)(fu)劑(如(ru)(ru)活性炭、分子篩等(deng));4.將(jiang)(jiang)容器(qi)(qi)密封(feng)并(bing)放置一(yi)段時間,使吸附(fu)(fu)劑吸附(fu)(fu)包(bao)材內部的(de)(de)溶(rong)(rong)劑殘(can)(can)(can)留(liu)物(wu);5.使用(yong)適(shi)當的(de)(de)儀器(qi)(qi)(如(ru)(ru)氣相色(se)(se)譜儀)對(dui)吸附(fu)(fu)劑進行分析,檢測(ce)溶(rong)(rong)劑殘(can)(can)(can)留(liu)物(wu)的(de)(de)含量。包(bao)裝材料應具(ju)有良好的(de)(de)透明度(du),方(fang)便用(yong)戶觀察藥品(pin)(pin)的(de)(de)顏色(se)(se)、形(xing)態等(deng)。藥品(pin)(pin)包(bao)材摩擦系數測(ce)試服(fu)務平臺(tai)

藥品包裝材料的材質(zhi)、結(jie)構和(he)使(shi)用方法(fa)需要(yao)經過嚴格(ge)的質(zhi)量控制和(he)檢(jian)測(ce)。上(shang)海(hai)檢(jian)測(ce)標準YBB00212004-2015

醫藥(yao)(yao)(yao)包(bao)(bao)(bao)(bao)裝(zhuang)材(cai)(cai)料(liao)(liao)(liao)檢(jian)(jian)測是一項重(zhong)(zhong)(zhong)(zhong)要的(de)(de)(de)(de)質(zhi)(zhi)量控制(zhi)措施,旨(zhi)在確(que)保(bao)藥(yao)(yao)(yao)品在包(bao)(bao)(bao)(bao)裝(zhuang)過(guo)程中不(bu)(bu)會受到有(you)(you)害物(wu)質(zhi)(zhi)的(de)(de)(de)(de)污(wu)染。這(zhe)(zhe)些(xie)有(you)(you)害物(wu)質(zhi)(zhi)包(bao)(bao)(bao)(bao)括(kuo)重(zhong)(zhong)(zhong)(zhong)金(jin)屬(shu)(shu)和有(you)(you)機溶(rong)劑(ji)(ji)(ji)等(deng),它們(men)可(ke)(ke)能(neng)(neng)對(dui)(dui)人體(ti)健康(kang)產(chan)生不(bu)(bu)良(liang)影響。因(yin)此,對(dui)(dui)醫藥(yao)(yao)(yao)包(bao)(bao)(bao)(bao)裝(zhuang)材(cai)(cai)料(liao)(liao)(liao)進(jin)(jin)行多(duo)方面的(de)(de)(de)(de)檢(jian)(jian)測是非常(chang)必(bi)要的(de)(de)(de)(de)。首先,重(zhong)(zhong)(zhong)(zhong)金(jin)屬(shu)(shu)是一類常(chang)見的(de)(de)(de)(de)有(you)(you)害物(wu)質(zhi)(zhi),如鉛、汞(gong)、鎘和鉻等(deng)。這(zhe)(zhe)些(xie)重(zhong)(zhong)(zhong)(zhong)金(jin)屬(shu)(shu)可(ke)(ke)能(neng)(neng)存在于(yu)包(bao)(bao)(bao)(bao)裝(zhuang)材(cai)(cai)料(liao)(liao)(liao)的(de)(de)(de)(de)原(yuan)材(cai)(cai)料(liao)(liao)(liao)中,或(huo)者(zhe)在生產(chan)過(guo)程中被添加進(jin)(jin)去。如果藥(yao)(yao)(yao)品接觸到含(han)有(you)(you)重(zhong)(zhong)(zhong)(zhong)金(jin)屬(shu)(shu)的(de)(de)(de)(de)包(bao)(bao)(bao)(bao)裝(zhuang)材(cai)(cai)料(liao)(liao)(liao),這(zhe)(zhe)些(xie)重(zhong)(zhong)(zhong)(zhong)金(jin)屬(shu)(shu)可(ke)(ke)能(neng)(neng)會滲入藥(yao)(yao)(yao)品中,從(cong)而對(dui)(dui)人體(ti)健康(kang)造(zao)成潛在的(de)(de)(de)(de)風(feng)險。因(yin)此,通(tong)過(guo)對(dui)(dui)醫藥(yao)(yao)(yao)包(bao)(bao)(bao)(bao)裝(zhuang)材(cai)(cai)料(liao)(liao)(liao)進(jin)(jin)行重(zhong)(zhong)(zhong)(zhong)金(jin)屬(shu)(shu)檢(jian)(jian)測,可(ke)(ke)以確(que)保(bao)藥(yao)(yao)(yao)品不(bu)(bu)會受到重(zhong)(zhong)(zhong)(zhong)金(jin)屬(shu)(shu)的(de)(de)(de)(de)污(wu)染。其次(ci),有(you)(you)機溶(rong)劑(ji)(ji)(ji)也是一類常(chang)見的(de)(de)(de)(de)有(you)(you)害物(wu)質(zhi)(zhi)。有(you)(you)機溶(rong)劑(ji)(ji)(ji)通(tong)常(chang)用于(yu)包(bao)(bao)(bao)(bao)裝(zhuang)材(cai)(cai)料(liao)(liao)(liao)的(de)(de)(de)(de)制(zhi)造(zao)過(guo)程中,如溶(rong)劑(ji)(ji)(ji)型膠(jiao)水、油墨和涂(tu)料(liao)(liao)(liao)等(deng)。這(zhe)(zhe)些(xie)有(you)(you)機溶(rong)劑(ji)(ji)(ji)可(ke)(ke)能(neng)(neng)會殘留在包(bao)(bao)(bao)(bao)裝(zhuang)材(cai)(cai)料(liao)(liao)(liao)中,如果藥(yao)(yao)(yao)品與這(zhe)(zhe)些(xie)有(you)(you)機溶(rong)劑(ji)(ji)(ji)接觸,可(ke)(ke)能(neng)(neng)會導致(zhi)藥(yao)(yao)(yao)品的(de)(de)(de)(de)質(zhi)(zhi)量下(xia)降,甚至對(dui)(dui)人體(ti)健康(kang)產(chan)生不(bu)(bu)良(liang)影響。因(yin)此,通(tong)過(guo)對(dui)(dui)醫藥(yao)(yao)(yao)包(bao)(bao)(bao)(bao)裝(zhuang)材(cai)(cai)料(liao)(liao)(liao)進(jin)(jin)行有(you)(you)機溶(rong)劑(ji)(ji)(ji)檢(jian)(jian)測,可(ke)(ke)以確(que)保(bao)藥(yao)(yao)(yao)品不(bu)(bu)會受到有(you)(you)機溶(rong)劑(ji)(ji)(ji)的(de)(de)(de)(de)污(wu)染。上(shang)海檢(jian)(jian)測標準YBB00212004-2015

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