小容量注射剂在灯检时检查外观的照度多少合适？

怀民快来赏月

求助，小剂量注射剂在灯检时检查外观的照度多少合适？有无出处？用的是澄明度检测仪，去看外观，看碳化啥的，

YM0a877cad

没有出处，参照药典可见异物检查法好了

sunguoqing

1000-1500lux
欧盟那边的更高

怀民快来赏月

sunguoqing 发表于 2024-11-12 16:06
1000-1500lux
欧盟那边的更高

有出处么？对安瓿瓶的颜色有要求么？

蒲公英669291427

用无色透明容器包装的无色供试品溶液，检查时被观察供试品所在处的光照度应为1000～1500lx；用透明塑料容器包装、棕色透明容器包装的供试品或有色供试品溶液，光照度应为2000～30001x；混悬型供试品或乳状液，光照度应增加至约40001x。
药典0902

Qiang.T

USP 1790 注射剂目视检查2016版中文    和          FDA行业指南：注射产品可见颗粒的检查-2021草案（中英文对照版）

怀民快来赏月

蒲公英669291427 发表于 2024-11-12 16:17
用无色透明容器包装的无色供试品溶液，检查时被观察供试品所在处的光照度应为1000～1500lx；用透明塑料容器 ...

看题呀 铁铁，外观的，不是澄清度的呀

怀民快来赏月

Qiang.T 发表于 2024-11-12 16:17
USP 1790 注射剂目视检查2016版中文    和          FDA行业指南：注射产品可见颗粒的检查-2021草案（中英 ...

铁铁，有更详细一点的么

九九swx

外观不是描述颜色等性状吗？灯检仪检查的是可见异物。参考药典标准就行，一般1000-1500Lx，欧盟跟FDA要求高一点，2000-3750 Lx

zxb6668

Inspection station for examining sterility test, media fill trials or for visible particles in
filled vials, ampoules or Prefilled Syringes
(PFS)
Apparatus1
- Vertical matte black panel
- Vertical non-glare white panel next to black
panel
- Adjustable lamp holder with shaded, white
“daylight” source and …a diffuser (…two 13W
fluorescent tubes, each 525 mm (20.7 in) in length
is suitable). …illumination at the viewing point is
…between 2,000 and 3,750 lux for clear glass ampoules or vials. Higher values are preferable for
coloured glass and plastic containers.
- under a maintenance plan to check lux. (Note lamp output can drop 50% in 12months)
Recommended procedure
- Gently swirl or invert each individual container, making sure that no air bubbles are introduced, and
observe for about 5 seconds in front of the white panel. Repeat …in front of the black panel.
- Record the presence of any particles or in the case of sterility testing or media fill trials, any
turbidity. Repeat the procedure for all containers.
Critical Inspection Parameters
• Lighting
Illumination Intensity
• JP - 1,000 lux
• WHO - 2,000-3,750 lux
• IESNA - “Difficult Inspection”, visual tasks of low contrast and small size - 1,000
lux, “Exacting Inspection”, visual tasks near threshold 3,000-10,000 lux
Intensity at container:
- 65-750 ft-candles / 215 ft-candles median
- 90-500 ft-candles / 225 ft-candles median
- 600-7,000 lux / 2,000 lux median
- 850-4,650 lux / 2,100 lux median
Uniformity
must have diffuser
Flicker
• Incandescent - No flicker
• Fluorescent - Possible flicker, check HF Ballast,
- Type
• Background
- Black / White
- 18% Gray (optional)
• Presentation and Manipulation
• Pace – pacing system for manual inspection, eg such as metronome
- Molded Glass Vials - 1 to 10 mL – a) 0.7-4 sec / 2 sec median
- Molded Glass Vials 11 to 100 mL - a) 1-28 sec / 6 sec median,
- Molded Glass Vials >100 mL a) 1-4 sec / 3 sec median,
- Tubing Glass Vials - 1 to 10 mL a) 0.7-60 sec / 8 sec median,
- Tubing Glass Vials 11 to 100 mL a) 1-60 sec / 15 sec median,
• Glass Ampoules - a) 4-42 sec / 4 sec median,
• Magnification optional but recommended
• Single or grouped up to 5 in group, but can be up to 15 for experienced operator

胜利者

透明溶液，常规

浅瞳1

多谢分享学习学习

江鱼眷夏

怀民快来赏月 发表于 2024-11-12 16:51
看题呀 铁铁，外观的，不是澄清度的呀

看外观也是按照药典标准执行，药液或者瓶子有颜色就按照高照度的标准检查。这个标准是一般标准，就是普遍性标准。国内上市就按chP执行，国外上市就按相应地区的法规执行

王小耐

药典里面有明确要求

白sxl6dzng

根据 0904 可见异物检查法、USP 1790注射剂目视检查、药典参看下
https://db.ouryao.com/yd2020/view.php?id=f82df0b96e
https://www.ouryao.com/thread-532716-1-1.html

昭泰生物

灯检照度这样规定的，透明瓶在1500-2500之间，棕色等安瓿瓶在2500-3200之间。法规要求在2000-3000勒克斯

EPO2B小青年1

每个国家或者地区都有对应的药典，可见异物检查法，如果多地申报，选择照度最严格的，棕色瓶有特殊要求，有时需要9000LX.