Pharmaceutical manufacturing questions

[Oroszlany Balazs]

Dear All, 

I am chasing a few pharmaceutical manufacturing expressions. While I can guess the meaning (and currently using some placeholder that might work), I still could not find a Japanese or a bilingual (Japanese-English) source where I can confirm whether I am right or wrong. 

1. 系外品　(or 系外排出品), as in: https://www.pmda.go.jp/files/000218642.pdf

2. This is for different pressures/forces in a tableting machine, from the lowest to the highest.

下限停止圧力 LLP
下限排出圧力 LEP
下限制御圧力 LCL
基準圧力 MEAN
上限制御圧力 HCL
上限排出圧力 HEP
上限停止圧力 HLP

The only online source I could find is this pattern: https://patents.google.com/patent/JP5707462B2/ja . But nothing similar turned out when I was looking, for example, for Low Ejection Pressure.

I would be grateful if you could help with the translations, or you could guide me to reference materials (online or offline) where I can get help with similar vocabulary.

Thank you,
Balazs

[Herman]

On 1/10/24 06:45, Oroszlany Balazs wrote:
> Dear All,
>
> I am chasing a few pharmaceutical manufacturing expressions. While I can
> guess the meaning (and currently using some placeholder that might
> work), I still could not find a Japanese or a bilingual
> (Japanese-English) source where I can confirm whether I am right or wrong.
>
> 1. 系外品　(or 系外排出品), as in:

"products diverted from the line"

Herman Kahn

[Oroszlany Balazs]

Thank you, Herman.

Balazs

[John Stroman]

Hello Balaz,

I ran the patent number (JP5707462B2)  through Google Patents and found the following. 

Warning: This may be MT output from Google Translate, but it seems to make sense.

LLP (unit: KN): Lower limit of abnormal pressure in the pressure control unit
LEP (unit: KN): Defective discharge pressure lower limit value of the pressure control unit
LCL (unit: KN): Mass control pressure lower limit value of pressure control unit
MEAN (unit KN): Pressure reference value of pressure control unit (equivalent to pressure control reference value PM)
HCL (unit: KN): Mass control pressure upper limit of the pressure controller
HEP (unit: KN): Upper limit value of defective discharge pressure in the pressure control unit
HLP (unit KN): Abnormal pressure upper limit value of the pressure control unit.

John Stroman

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[John Stroman]

Hello Balaz,

Sorry, but I should have given you the Japanese in case you wanted to translate it yourself.

[0108]

（圧力制御部の各制御圧力値関連記号）
ＬＬＰ(単位ＫＮ) ：圧力制御部の異常圧力下限値
ＬＥＰ(単位ＫＮ) ：圧力制御部の不良排出圧力下限値
ＬＣＬ(単位ＫＮ) ：圧力制御部の質量制御圧力下限値
ＭＥＡＮ(単位ＫＮ) ：圧力制御部の圧力基準値（圧力制御基準値ＰＭに相当）
ＨＣＬ(単位ＫＮ) ：圧力制御部の質量制御圧力上限値
ＨＥＰ(単位ＫＮ) ：圧力制御部の不良排出圧力上限値
ＨＬＰ(単位ＫＮ) ：圧力制御部の異常圧力上限値。

John

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[Oroszlany Balazs]

Thanks, John. 

This is really helpful. My problem is that since the abbreviations are clearly from english (L - low, H-high, P-pressure, E - eject instead of discharge etc.), there must be a document where they are explained.

(I am working on batch records, so there is little or no context that would help).

But with your help, I will figure out something - and if the client corrects it, then I will update the list.

Best regards,
Balazs

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[John Stroman]

Hello again Balaz,

By searching Google with some of the abbreviations in quotation marks, I found a Korean patent publication (KR100684202B1) that discusses pressure settings for a tableting machine. 

The Google translation output is questionable, but hovering over the relevant paragraph shows the original Korean with English in parentheses. I cannot copy the paragraph in Korean, but the English version is as follows:  HEP (High Eject Pressure), HCP (High Control Pressure), REF (Reference), LCP (Lower Control Pressure), LEP ( Lower Eject Pressure) HSP (High Stop Pressure)

I assume that MEAN refers to the middle setting or reference setting as noted in the KP. For LCP and LEP, I suspect "lower" should simply be "low" to correspond with "high."

Best of luck on tracking these down.

John

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