Questions & Answers:Semi-Automated Visual Inspection
半自動(dòng)目視檢查的問答
In a webinar onsemi-automated visual inspection of parenteralia many basic questionsregarding visual inspection and alsospecific questions with regard to semi-automated inspection were asked and answered.
在關(guān)注射劑半自動(dòng)目視檢查的網(wǎng)絡(luò)研討會(huì)中，詢問了許多有關(guān)目視檢查和半自動(dòng)檢查的問題。
Q: Our productis a non-transparent oil emulsion in 250 ml and 500 ml bags. Is asemi-automated inspection with cameras conceivable?
問：我們的產(chǎn)品是250毫升和500毫升袋裝不透明油乳液。使用攝像頭進(jìn)行半自動(dòng)檢查是否可行？
A: Another method for particle detection should be used. The visualinspection of such a 500 ml bag is almost impossible. To ensure that the bag isfree of particles another method like filtration should be used.
答：應(yīng)使用另一種微粒檢測方法。此種500 毫升袋的目視檢查幾乎是不可能的。為了確保袋子沒有顆粒，應(yīng)采用另一種方法，如過濾。
Q: A questionregarding the qualification of a new production line. How to proceed if youhave neither a qualified system nor qualified staff? Both types of qualification need each other.
問：關(guān)于新生產(chǎn)線的確認(rèn)問題。如果既沒有已確認(rèn)的系統(tǒng)，也沒有已確認(rèn)的員工，如何進(jìn)行？這兩種類型的確認(rèn)都需要。
A: Qualified employees for manual control must be available. Using them, theprocess of semi-automated visual inspection can be qualified. It is the same ifa fully automated system is to be qualified.
答：必須具備可人工操作的已確認(rèn)的員工。可使用它們進(jìn)行半自動(dòng)目視檢查的確認(rèn)。如果要進(jìn)行全自動(dòng)系統(tǒng)的確認(rèn)，也是同理。
Q: Regardingthe design of a semi-automated machine: Are colors other than black and whiteallowed? As in manual testing. Would grey be better? Is a white backgroundenough?
問：關(guān)于半自動(dòng)設(shè)備的設(shè)計(jì)：是否允許使用黑白以外的顏色？與人工檢測一樣?；疑珪?huì)更好嗎？僅白色背景足夠嗎？
A: Black is the best color here. Once in terms of light reflections andoperator fatigue. Grey would also work. In Annex I, there is no specificrequirement for the background colour of a semi-automated system.
A：黑色是最好的顏色。考慮光的反射和操作人員的疲勞度。灰色也可以。GMP附錄1沒有對半自動(dòng)系統(tǒng)的背景顏色的要求。
Q: What isrequired for the certification of operators and how can eye breaks / inspectiontimes be documented?
問：操作人員的確認(rèn)需要什么，如何記錄休息/檢查的時(shí)間？
A: Operators should have an ophthalmologic certificate (80% normal vision) anda qualification that proves that they can sort out the required defects. Pausetimes / inspection times should be recorded using log on / log off of theoperator; manually by hand or automated.
答：操作人員應(yīng)擁有眼科證明（80% 的正常視力）并證明自己能夠發(fā)現(xiàn)所要求缺陷的資質(zhì)。應(yīng)使用操作員上機(jī)/下機(jī)記錄休息/檢查時(shí)間；人工或自動(dòng)記錄。
Q: What is anoptimal illumination level (in lux) for the inspection of plastic containers insemi-automated systems? And is there a type of illumination you prefer?
問：在半自動(dòng)化系統(tǒng)中檢查塑料容器的最佳光照水平（以勒克斯表示）是多少？建議使用哪種類型的光照？
A: Higher illuminance levels than glass, but it is up to you to determine thebest illumination for this. Definitely higher than 37500 lux. LED lighting maybe preferred.
答：應(yīng)使用比玻璃容器更高的照度，但也要根據(jù)你的情況確定最佳照明。當(dāng)然肯定高于 37500 lux ?？梢允走x LED 照明。
Q: Should thesmallest particle sizes determined by a Knapp study be systematically includedin the test kits for qualification?
問：由Knapp 試驗(yàn)確定的最小顆粒尺寸是否應(yīng)系統(tǒng)地包含在確認(rèn)測試套件中？
A: Yes.
答：是的。
Q: What is youropinion / experience of using polarized lenses in a semi-automated system?
問：在半自動(dòng)系統(tǒng)中使用偏振鏡片您有何看法/經(jīng)驗(yàn)？
A: Not good. The naked human eye is best and this is what is expected.
答：不好。肉眼是最好的，這也是所要求的。
Q: Is thatcorrect that the visual inspection in front of black and whitebackground on a fully automated system should not exceed 2 seconds?
問：在全自動(dòng)系統(tǒng)上過黑白背景目視檢查的實(shí)際不應(yīng)超過 2 秒，這是否正確？
A: No. The speed of the semi-automated conveyor belt should not be too fast.The maximum speed should mathematically be no less than 2 seconds per object inthe inspection area for the operator.
答：不正確。半自動(dòng)傳送帶的速度不應(yīng)太快。每個(gè)物品在操作員的檢查區(qū)域的實(shí)際應(yīng)不小于 2 秒。
Q: Are thereany special requirements for semi-automated inspection for Japan?
問：日本對半自動(dòng)檢查有什么特殊要求嗎？
A: No. Make sure to sort out all particles and cosmetic defects when youdeliver to Japan.
答：沒有。出口日本市場時(shí)，應(yīng)區(qū)分所有顆粒和外觀缺陷。
Q: For acomparative semi-automated versus manual inspection study, do the test kitsizes have to be the same?
問：對于半自動(dòng)與人工燈檢對比研究，測試套件的大小必須相同嗎？
A: Yes.
答：是的。
Q: Is thatcorrect that after a 100% semi-automated inspection is completed, a manualinspection based on ISO 2859-1 should be performed?
問：在完成 100% 半自動(dòng)檢查后，應(yīng)執(zhí)行基于 ISO 2859-1 的人工檢查，這是否正確？
A: Yes, i.e. sampling based on ISO 2859-1 and manual testing of the samples.The size of the AQL sampling depends on the batch size. Inspection Level IIshould be used.
答：是的，也就是，基于ISO 2859-1的抽樣和人工檢查。AQL 抽樣的大小取決于批量大小。應(yīng)使用檢查級別 II。
Q: How oftenshould manual inspection operators be qualified (note: requalified)?
問：人工檢查的操作員應(yīng)多久進(jìn)行一次確認(rèn)（注：再確認(rèn)）？
A: At least once a year.
答：至少每年。
Q: The settingsof the semi-automated system (illumination, rotation speed, etc.) should beselected in such a way that a sufficient inspection process is guaranteedwithout adversely affecting the physico-chemical properties of the product. Howdo you ensure this during qualification?
問：半自動(dòng)系統(tǒng)的設(shè)置（照明、電機(jī)轉(zhuǎn)速等）的選擇應(yīng)保證足夠的檢測過程，而不會(huì)對產(chǎn)品的物理化學(xué)性能產(chǎn)生不利影響。在確認(rèn)期間，如何確保這一點(diǎn)？
A: For this purpose, you need to perform a stability study, e.g. with thevalidation batches, and show that your inspection process has no influence onthe product quality.
答：為此，需要執(zhí)行穩(wěn)定性研究，例如使用驗(yàn)證批次，并證明檢查過程對產(chǎn)品質(zhì)量沒有影響。
Q: Do you havespecial experience with different inspection angles in semi-automated systemswhen testing liquids or lyophilized products.
問：在測試液體或凍干產(chǎn)品時(shí)，你是否具有在半自動(dòng)系統(tǒng)中使用不同檢查角度的特殊經(jīng)驗(yàn)。
A: Through the lens of the semi-automated machine, the inspection angle shouldnot influence the inspection. The lens should be placed so that the operatorcan see the complete unit. For lyophilized products, the only difference isthat the inspection time for the operator should be shortened because visualinspection of the white powder will cause eye fatigue more quickly.
答：通過半自動(dòng)機(jī)器的鏡頭，檢查角度不應(yīng)影響檢測。鏡頭應(yīng)放置以使操作人員可以看到整個(gè)的產(chǎn)品。對于凍干產(chǎn)品，唯一的區(qū)別是，操作人員的檢查時(shí)長應(yīng)縮短，因?yàn)閷Π咨勰┻M(jìn)行目視檢查會(huì)更快地導(dǎo)致眼睛疲勞。
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