Ko te PQ te waahi whakamana e whakamahi ana i te ruuma whakahoromata Ethylene oxide ki te whakaatu kei te mahi tonu nga taputapu whakahoromata Ethylene oxide i runga i nga paearu whakaae kua whakaritea, ka puta mai he hua mokemoke me te whakatutuki i nga whakaritenga kua tohua.
Me whakahaere te PQ mo ia tukanga hou me/ranei hua hei whakamana hei whakaatu i te u o te tukanga ki nga paearu whakaae kua tautuhia me te kaha ki te tuku i te SAL e hiahiatia ana ki te hua.Kei roto i te PQ nga tohu mahi microbiological me te tinana ka mahia i roto i nga taputapu whakahoromata Ethylene oxide i whakamahia hei whakahoro i te hua.
During PQ process, the package of the product and loading mode of the product should be specified; Select representative products or materials whose packaging and material composition can cover all the product to be sterilized or the entire product family.
During PQ process, the package of the product and loading mode of the product should be specified; Select representative products or materials whose packaging and material composition can cover all the product to be sterilized or the entire product family.
In general, MPQ and PPQ are performed simultaneously.If PPQ is performed in parallel with at least three MPQ runs, then a minimum of one additional PPQ run shall be performed using the full cycle process specification. Physical PQ (PPQ) shall demonstrate that the specified acceptance criteria are met throughout the load for the duration of the proposed routine process specification.
Ka mahia te PQ i runga i te whakaurunga o nga hua hou, i whakarerekehia ranei, i te kete, i te whirihoranga uta, i te ruuma whakamaoritanga o te Ethylene oxide, i nga tawhā tukanga ranei mena ka rite ki tetahi hua kua whakamanahia i mua, ki te takai, ki te whirihoranga kawenga Te ruuma whakamaoritanga o te Ethylene oxide, te tukanga ranei kua tuhia.
PQ manatoko Ethylene waikura tukanga ruma whakahoromata
Ko te tikanga o te manatoko PQ ko te tikanga: mahia he huringa hautanga i te tuatahi, ka whakamatau i te mana o te hua i muri mai.
hautau
whakahoromatatanga huringa; whakatairitehia te hononga aukati EO i waenga i te IPCD, te EPCD me nga hua tohu (ko te hua e tumanakohia ana ko EPCD > IPCD > Hua,); Tirohia te ISO-11737-2 mo nga whakaritenga whakamatautau kei roto i te huringa hautau.
Mahi i te haurua huringa ki te whakamatau i te reproducibility o te tukanga whakahoromata me te painga whakahoromata; Mena ka whakamahia te tikanga overkill, karekau he IPCD pai i roto i te haurua o te huringa. Ko te EPCD pai i roto i te haurua o te huringa ka whakaaetia mena kua whakaatuhia he kaha ake i te IPCD e whakarato ana i te
“
wero kino rawa atu
”
mo te tukatuka mahinga.
Ko nga tawhā whakahoromata ka whakatauhia e nga tawhā hurihanga katoa, na reira ka mahia nga toenga wero i roto i te huringa katoa ki te whakatau i te wa whakangao. I te mea kua whakamatauhia te whai huatanga o te mahi whakahoromata i roto i te huringa hautanga me te haurua o nga huringa, ka taea e te EPCD te whakamana te whakamaaramatanga.
If, in any of these runs, sterility or product functionality requirements are not met, an investigation should be conducted to determine if additional qualification runs are necessary. If process parameters cannot be maintained within the defined limits, an investigation should be conducted. If modifications are made, additional runs must be necessary.
Annual PQ in Ethylene oxide sterilization chamber process
Ko te arotake o te PQ me aromatawai he mana tonu te tukanga whakahoromata mo te hua kua tohua.Ka taea te whakaiti MPQ/PPQ i etahi ahuatanga, hei tauira. ki te manatoko i te tika tonu o te parenga o te PCD o roto i roto i te uta hua ki te parenga o te taumahatanga o te hua, i muri ranei i te waahi kua tautuhia, ki te whakaatu tohu kaore he huringa pohehe mai i te rangahautanga o mua. Ko te tikanga ka uru atu ki tenei, iti, kotahi hautanga, haurua ranei te haurua o te huringa, tae atu ki te inenga o te pāmahana me te makuku. Ka taea hoki te whakamahi i nga huringa hautau i roto i te ruuma whanaketanga hei tautoko i te kaupapa whakawhiwhi tohu, engari me mahi ano te whakawhiwhinga o te ruuma whakangao ki roto i te ruma whakaputa.
Aromatawai o te orite
1.Process Equivalence?Ethylene oxide sterilization equipment that delivers the same process parameters, having undergone IQ me OQ, shall be qualified either.
2. in the same manner as the original chamber, or using a reduced MPQ that demonstrates the delivery of the required level of microbiological lethality and PPQ to demonstrate temperature and humidity uniformity of the load and control by the production chamber. The rationale for this reduced qualification shall be recorded and documented.
3. The influence of different geographical locations on the product or load properties shall be determined.
4. Ko te whakaorite o te tukanga he tikanga e whakamahia ana hei whakaatu he rite tonu te tukanga whakahoromata kua whakamanahia e te rua, neke atu ranei nga waahanga, huinga taputapu whakahoromata Ethylene oxide. Kaore e hiahiatia kia rite te tinana o nga taputapu. Ahakoa ko nga tawhā ka tukuna mai e nga taputapu kaore i te rite ki te tatauranga, ka rite tonu nga tikanga tuku mena ka taea e ratou katoa te whakahaere i te mahi i roto i nga tikanga kua tautuhia, kua whakamanahia.
5. Ko te riterite o te tukanga i waenga i nga taputapu maha hei whakaiti i te nui o nga whakamatautau e tika ana kia whakamanahia te tukanga. Me whakamana te tukanga whakahoromata i roto i te ruma kotahi. Ko nga taputapu e toe ana ka paheke te PQ mena kua whai tohu whakaurunga (IQ) me te tohu whakahaere (OQ) te toenga taputapu (tirohia te 9.2 me te 9.3). Ka taea hoki te whakamahi i te taurite ki te whakaiti i te tohu tohu mo etahi momo taputapu. Ko nga taputapu e whakamahia ana ki te tuku i te tukanga whakahoromata he ruma, ruma ranei me nga punaha whakahaere taapiri. Kei roto pea i tetahi whare tukatuka, i roto ranei i te maha o nga whakaurunga. Ka taea te whakamahi takitahi tenei taputapu ki te tuku i nga tikanga o te tukanga, a he rite tonu te hoahoa, he rereke ranei te rahi, te whānuitanga ranei o nga taputapu taapiri.
6. Ko te riterite o te tukanga i waenga i nga taputapu maha hei whakaiti i te nui o nga whakamatautau e tika ana kia whakamanahia te tukanga. Me whakamana te tukanga whakahoromata i roto i te ruma kotahi. Ko nga taputapu e toe ana ka paheke te PQ mena kua whai tohu whakaurunga (IQ) me te tohu whakahaere (OQ) te toenga taputapu (tirohia te 9.2 me te 9.3). Ka taea hoki te whakamahi i te taurite ki te whakaiti i te tohu tohu mo etahi momo taputapu. Ko nga taputapu e whakamahia ana ki te tuku i te tukanga whakahoromata he ruma, ruma ranei me nga punaha whakahaere taapiri. Kei roto pea i tetahi whare tukatuka, i roto ranei i te maha o nga whakaurunga. Ka taea te whakamahi takitahi tenei taputapu ki te tuku i nga tikanga o te tukanga, a he rite tonu te hoahoa, he rereke ranei te rahi, te whānuitanga ranei o nga taputapu taapiri.
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