Kev Hloov Kho Tseem Ceeb: 2025 Khoom Noj- Qib Roj Hmab Gasket Regulations - Yam Uas Yuav Tsum Paub Tam Sim No
Lub Peb Hlis 16, 2025, yog hnub tseem ceeb rau cov tuam txhab roj hmab gasket muab cov zaub mov, dej haus, thiab kev lag luam tshuaj. Cov European Union Txoj Cai Tshiab (EU) 2025/351 qhia txog cov qauv kev coj dawb huv nruj dua, txhim kho cov kev xav tau ntawm kev taug qab, thiab nthuav cov ntaub ntawv tseem ceeb uas yuav hloov kho cov tswv yim ua raws li cov zaub mov-hu rau cov khoom siv roj hmab. Ua ke nrog kev tswj hwm FDA tsis tu ncua hauv Tebchaws Meskas, cov tuam txhab lag luam ntsib cov kev hloov pauv tseem ceeb tshaj plaws hauv ntau xyoo dhau los. Cov lus qhia dav dav no piav qhia txog qhov hloov pauv, leej twg cuam tshuam, thiab yuav ua li cas txhawm rau ua raws.
1. EU Txoj Cai (EU) 2025/351: Qhov Kev Hloov Kho Loj Tshaj Plaws
Dab tsi hloov thaum Lub Peb Hlis 16, 2025?
Lub European Commission tau tshaj tawm Txoj Cai (EU) 2025/351 thaum Lub Ob Hlis 21, 2025, uas tau pib siv rau lub Peb Hlis 16, 2025. Thaum lub hom phiaj tseem ceeb yog tsom rau cov khoom noj khoom haus yas, cov kev cai no cuam tshuam rau cov tuam txhab roj hmab gasket vim:
- Cov txheej yas hauv gaskets yog tam sim no tswj:Plastic coatings ua gaskets nyob rau hauv lub kaus mom thiab kaw poob nyob rau hauv cov kev cai nruj
- Ntau-cov ntaub ntawv gaskets ntsib kev tshuaj xyuas zoo dua:Cov roj hmab hybrid- cov khoom ntim yas yuav tsum ua tau raws li cov qauv elastomer thiab yas
- Supply chain cov ntaub ntawv nthuav dav:Cov khoom siv roj hmab gasket yuav tsum muab cov ntaub ntawv ntxaws ntxaws thiab cov ntaub ntawv purity raws li kev thov
- Tshaj Tawm Txog Kev Ua Raws Cai (DoC) cov cai nruj nruj:Cov ncauj lus kom ntxaws ntxiv yuav tsum tau muaj nyob rau txhua theem ntawm cov khoom siv
Hnub kawg tseem ceeb:Cov khoom lag luam thawj zaug tso rau tom khw tom qab lub Cuaj Hlis 16, 2026, yuav tsum ua raws li cov cai tshiab. Cov khoom muag uas twb muaj lawm tsim nyob rau hauv cov qauv qub tuaj yeem muag tau kom txog rau thaum cov khoom lag luam poob, tab sis cov khoom tshiab yuav tsum ua kom tau raws li cov kev xav tau tshiab tam sim ntawd.
Cov kev cai tseem ceeb cuam tshuam rau Rubber Gasket Manufacturers
| Qhov Xav Tau | Hloov dab tsi | Kev cuam tshuam rau Roj Hmab Gaskets |
|---|---|---|
| Purity Standards | Cov txheej txheem nruj rau UVCB cov khoom thiab cov khoom siv ntuj tsim | Ntuj roj hmab tebchaw yuav tsum tau txhim khu purity ntaub ntawv |
| Kev txwv kev tsiv teb tsaws chaw | NIAS risk assessment required if migration >0.00015 mg/kg | Extractables xeem yuav tsum tau rau cov formulations tshiab |
| Traceability | Txhim khu kev taug qab rau cov khoom siv rov ua dua tshiab | Gaskets nrog cov ntsiab lus rov siv dua yuav tsum muaj kev tswj xyuas kev sib kis |
| Cov ntaub ntawv | Cov ntsiab lus tsim nyog yuav tsum tau ua raws li kev thov | Cov ntaub ntawv sau ua tiav yuav tsum tau tshuaj xyuas -npaj |
| Kev sau npe | Cov lus qhia yuav tsum tau siv rau cov khoom noj khoom haus rov qab siv tau | Reusable gaskets xav tau cov neeg siv khoom- ntsib cov lus qhia siv |
2. FDA 21 CFR 177.2600: Tam sim no Teb Chaws Asmeskas Cov Kev Cai thiab Kev Cai Lij Choj
FDA Ua Raws Li Txoj Cai rau Roj Hmab Gaskets
Hauv Tebchaws Meskas, cov roj hmab gaskets npaj rau kev sib cuag zaub mov yuav tsum ua raws li FDA 21 CFR 177.2600, uas tsim cov qauv kev nyab xeeb rau cov khoom siv roj hmab. Tsis zoo li EU cov kev hloov tshiab tsis ntev los no, FDA lub moj khaum tseem nyob ruaj khov tab sis kev tswj hwm tau nce ntxiv hauv 2025.
FDA 21 CFR 177.2600 Cov Lus Qhia Tseem Ceeb:
Tshooj A-D:Sau cov khoom xyaw uas pom zoo thiab qhov txwv tsis pub ntau rau cov khoom siv roj hmab
Ntu E:Extractives txwv rau aqueous zaub mov tiv tauj
- Thawj 7 teev: Tsawg dua lossis sib npaug li 20 mg ib square inch
- 2 teev tom ntej: Tsawg dua lossis sib npaug li 20 mg ib square inch
Ntu F:Extractives txwv rau kev sib cuag zaub mov fatty (n-hexane)
- Thawj 7 teev: Tsawg dua lossis sib npaug li 175 mg ib square inch
- 2 teev tom ntej: Tsawg dua lossis sib npaug li 4 mg ib square inch
Cov ntsiab lus tseem ceeb:FDA tsis "pom zoo" cov ntaub ntawv gasket. Hloov chaw, cov tuam txhab lag luam yuav tsum ua tus kheej- lees paub kev ua raws li kev ua kom pom tias lawv cov khoom siv roj hmab ua tau raws li cov khoom siv thiab cov khoom siv ntxiv. Daim ntawv pov thawj no yuav tsum tau txais kev txhawb nqa los ntawm cov ntaub ntawv xeem thiab cov ntaub ntawv tsim nyog.
2025 FDA Txoj Cai Lij Choj
Kev tshuaj xyuas FDA thiab kev ceeb toom ntshuam hauv xyoo 2025 qhia txog kev tshuaj xyuas ntau ntxiv hauv peb thaj chaw:
- Extractables kuaj xyuas:FDA tab tom thov daim ntawv pov thawj tiag tiag, tsis yog cov lus hais ua raws
- PFAS nthuav tawm cov ntsiab lus:Loj hlob kev txhawj xeeb txog ib - thiab polyfluoroalkyl tshuaj (PFAS) hauv fluoroelastomer gaskets
- Supplier audit trails:Cov neeg tsim khoom yuav tsum ua kom pom kev taug qab rau cov khoom siv raw nrog cov ntaub ntawv ua raws
3. Cov khoom siv -Txoj kev ua raws cai
FDA-Ua raws cov khoom siv roj hmab: Cov ncauj lus kom ntxaws
| Hom khoom | FDA Txoj Cai | EU Status | Cov ntsiab lus tseem ceeb ua raws |
|---|---|---|---|
| Dawb EPDM | 21 CFR 177.2600 Nws | Txoj Cai Lij Choj 1935/2004 | Yuav tsum siv cov khoom xyaw dawb - cov npe; peroxide-kho zoo dua rau kev sib cuag zaub mov |
| Dawb Nitrile (NBR) | 21 CFR 177.2600 Nws | Txoj Cai Lij Choj 1935/2004 | Zoo heev rau cov zaub mov oily; yuav tsum xeem dhau n-hexane extractives test |
| Silicone (VMQ) | 21 CFR 177.2600 Nws | Txoj Cai Lij Choj 1935/2004 | Platinum- kho tau xwb (kev kho peroxide tsis pom zoo rau kev sib cuag zaub mov) |
| FKM (Viton) | 21 CFR 177.2600 Nws | Txoj Cai Lij Choj 1935/2004 | High -temp applications; yuav tsum sau PFAS cov ntsiab lus rau EU |
| Dawb Neoprene (CR) | 21 CFR 177.2600 Nws | Txoj Cai Lij Choj 1935/2004 | Lub hom phiaj zoo; USDA pom zoo rau kev ua nqaij / nqaij qaib |
| PTFE | 21 ZPO 177.1550 | Cov Lus Qhia 93/11/EEC (N-nitrosamines) | Kev cai sib cais; fillers kuj yuav tsum yog zaub mov- qib pom zoo |
Case Study: Dawb EPDM Gasket Ua raws li cov khoom siv mis nyuj
Daim ntawv thov:Valve gaskets rau cov khoom siv mis nyuj ua haujlwm (rov ua dua chav ua kom tsis muaj menyuam)
Regulatory Requirements:
- FDA 21 CFR 177.2600 ua raws
- EU Cov Txheej Txheem Kev Cai 1935/2004
- 3-A Sanitary Standards
- Kub tiv taus: -40℃rau +150℃(steam sterilization)
Cov kauj ruam ua pov thawj:
Kauj ruam 1:Material Formulation Audit
Txheeb xyuas tag nrho cov khoom xyaw hauv FDA 21 CFR 177.2600 Tshooj A-D. Siv peroxide-kho dawb EPDM (Shore A 60) los ntawm tus neeg muag khoom muaj ntawv pov thawj.
Kauj ruam 2:Extractable Testing
Kev ntsuas dej tawm (reflux ntawm 100 degree): Thawj 7 teev=8.2 mg/in², Tom ntej 2 teev=3.1 mg/in². Ob leeg hauv qab FDA txwv (20 mg / in²).
Kauj Ruam 3:Cov ntaub ntawv pob
Npaj Tshaj Tawm Txog Kev Ua Raws Cai suav nrog:
- Cov ntaub ntawv pov thawj ntawm cov khoom siv polymer
- Extractables test reports los ntawm ISO 17025 accredited lab
- Kev tsim cov txheej txheem khiav daim duab qhia GMP ua raws
- Traceability records linking batch number to test certificates
Kauj Ruam 4:EU Kev Pom Zoo Ua Raws Cai
Paub meej tias tsis muaj tshuaj muaj kev txhawj xeeb heev (SVHC) raws li REACH
Txheeb xyuas ua raws li Kev Ua Haujlwm Zoo (EC) 2023/2006
Qhov tshwm sim:Gaskets tau pom zoo siv rau hauv 15 lub chaw ua khoom noj mis nyuj thoob plaws US thiab EU kev lag luam. Ua kom tiav cov ntaub ntawv pob txo cov neeg siv khoom pom zoo los ntawm 6 lub hlis mus rau 3 lub lis piam.
4. Kev Ua Raws Li Qhov Tseem Ceeb: FDA pom zoo vs. FDA Ua raws li qib zaub mov
Kev nkag siab txog cov ntsiab lus tseem ceeb yog qhov tseem ceeb rau kev ua raws li kev thov kom raug thiab zam kev ua txhaum cai:
| Lub sij hawm | Kev siv kom raug | Kev xav tau | Common Misuse |
|---|---|---|---|
| FDA pom zoo | INCORRECT rau roj hmab gaskets | FDA tsis pom zoo rau cov khoom gasket tus kheej | Cov ntaub ntawv ua lag luam cuav thov "FDA Pom Zoo Gaskets" |
| Ua raws li FDA | YOG thaum muaj ntawv pov thawj | Khoom raws li 21 CFR 177.2600; extractables xeem dhau; cov ntaub ntawv pov thawj muaj | Kev lees paub ua raws yam tsis muaj cov ntaub ntawv xeem tiag tiag |
| FDA Qib | Kev lag luam tsis raug cai | Tsis muaj lus txhais; feem ntau txhais tau tias tsim nrog dawb- cov khoom xyaw uas tau teev tseg tab sis yuav tsis muaj kev sim | Siv los hloov "FDA Compliant" yam tsis muaj kev sim |
| Qib zaub mov | General lub sij hawm xwb | Tsis muaj kev cai txhais; tej zaum yuav tsis ua raws li FDA lossis EU cov cai | Piv txwv tias "qib zaub mov" sib npaug ntawm kev ua raws cai |
| Food Safe | Lub sij hawm ua lag luam nkaus xwb | Tsis yog kev cai cais | Siv cov ntawv pov thawj kev ua raws cai |
Kev ceeb toom raws cai:Kev thov "FDA Pom Zoo" rau cov roj hmab gaskets yog qhov tseeb tsis raug thiab yuav ua rau kev tshaj tawm cuav. FDA tuaj yeem tshaj tawm tsab ntawv ceeb toom, tsis kam nkag mus rau cov khoom lag luam, thiab ua raws li kev cai lij choj tawm tsam cov tuam txhab ua cov ntawv foob tsis raug. Ib txwm siv "FDA Compliant" nrog cov ntaub ntawv txhawb nqa.
5. Kauj Ruam -los ntawm - Kauj Ruam Kev Ua Raws Cai
Rau Gasket Manufacturers
Theem 1: Raw Material Qualification (Ua ntej Production)
- Tau txais daim ntawv pov thawj ntawm tus neeg muag khoom:Thov FDA ua raws li daim ntawv pov thawj los ntawm polymer, muab tub lim, thiab cov khoom siv ntxiv
- Txheeb xyuas cov npe khoom xyaw:Hla - xyuas tag nrho cov khoom tiv thaiv FDA 21 CFR 177.2600 cov tshuaj pom zoo
- Tshawb xyuas REACH ua raws:Rau EU kev lag luam, paub meej tias tsis muaj SVHC siab dua 0.1% w / w
- Cov ntaub ntawv traceability:Tsim kom muaj batch taug qab qhov system txuas cov ntaub ntawv raw rau cov khoom tiav
Theem 2: Kev Ntsuas Cov Khoom (Pib thiab Lub Sijhawm)
- Kev ntsuas dej extractives:Raws li FDA 21 CFR 177.2600 Ntu E (dej distilled, reflux kub, 9 teev tag nrho)
- n-Kev kuaj Hexane extractives:Raws li FDA 21 CFR 177.2600 Ntu F (rau cov khoom noj rog, 9 teev tag nrho)
- Kev kuaj kev tsiv teb tsaws chaw (EU):Yog tias xav tau, siv cov simulants tau teev tseg hauv Txoj Cai (EU) 10/2011
- Kev tshuaj xyuas lub cev muaj zog:Paub meej tias hardness, tensile zog, elongation raws li specifications
- Siv cov chaw kuaj pom zoo:ISO / IEC 17025 cov chaw kuaj pom zoo rau txhua qhov kev xeem ua raws
Theem 3: Kev npaj cov ntaub ntawv
| Hom ntaub ntawv | Cov ntaub ntawv xav tau | Hloov tshiab zaus |
|---|---|---|
| FDA Daim Ntawv Pov Thawj Ua Raws Cai | Cov ntaub ntawv txheeb xyuas, CFR siv, hnub txiav txim siab ua raws cai, kos npe rau lub luag haujlwm | Raws li kev hloov pauv |
| EU Tshaj Tawm Txog Kev Ua Raws Cai | Tus neeg ua lag luam tus neeg ua lag luam, cov lus piav qhia ntawm cov khoom, hnub tshaj tawm, cov lus qhia ua raws, cov xwm txheej ntawm kev siv | Raws li cov khoom / txheej txheem hloov |
| Extractables Test Reports | Cov qauv kev xeem, kev txheeb xyuas tus qauv, cov txiaj ntsig nrog kev txwv, kev lees paub hauv chav kuaj, hnub xeem | Txhua xyoo los yog ib batch |
| Cov ntaub ntawv tsim tawm | Ua kom tiav cov khoom xyaw nrog CAS tus lej, feem pua, cov ntaub ntawv xa khoom | Nyob rau hauv lub formulation version |
| Cov ntaub ntawv GMP | Kev tsim cov txheej txheem piav qhia, cov txheej txheem tswj kom zoo, kev tiv thaiv kev sib kis | Txhua xyoo |
Rau Cov Neeg Muag Khoom thiab Cov Kws Ua Haujlwm
Supplier Evaluation Checklist:
- ☐ Thov FDA daim ntawv pov thawj kev ua raws cai tshwj xeeb rau cov khoom siv gasket thiab qhov loj me
- ☐ Tshawb xyuas cov ntaub ntawv xeem uas tau muab sau tseg rau hauv 12 lub hlis dhau los
- ☐ Paub qhov chaw kuaj ISO/IEC 17025 kev lees paub
- ☐ Saib Xyuas Kev Tshaj Tawm Txog Kev Ua Raws Cai rau EU kev lag luam (yog tias tsim nyog)
- ☐ Tshawb xyuas REACH SVHC tshaj tawm rau EU ua raws
- ☐ Txheeb xyuas cov chaw tsim khoom muaj ntaub ntawv GMP
- ☐ Paub meej tias muaj batch traceability system
- ☐ Thov qauv rau kev kuaj xyuas tus kheej (rau cov ntawv thov tseem ceeb)
Qhov Zoo Tshaj Plaws:Tsim cov npe neeg muag khoom pom zoo (AVL) nrog kev tshuaj xyuas cov ntaub ntawv ua raws txhua xyoo. Xav kom cov neeg muag khoom ceeb toom rau koj tam sim ntawd txog kev hloov pauv, hloov pauv cov khoom siv raw, lossis kev hloov chaw tsim khoom uas tuaj yeem cuam tshuam rau kev ua raws li txoj cai.
6. Cov qauv thiab cov ntawv pov thawj ntxiv
Tshaj li FDA thiab EU: Kev lag luam-Cov Lus Qhia Tshwj Xeeb
| Txuj | Muab Lub Cev | Daim ntawv thov | Cov Lus Qhia Tseem Ceeb |
|---|---|---|---|
| 3-A Sanitary Standards | 3-A Sanitary Standards Inc. | Cov khoom siv mis thiab khoom noj khoom haus | Material compatibility, cleanability, du nto, tsis muaj microbial harborage |
| NSF/ANSI 51 | NSF International | Khoom siv khoom noj khoom haus | Cov khoom siv kev nyab xeeb, kev kuaj kev rho tawm, tsis kam rau cov tshuaj ntxuav |
| USP Chav Kawm VI | Teb Chaws Asmeskas Pharmacopeia | Kev siv tshuaj thiab kev kho mob | Kev kuaj ntshav biochemical (implantation, systemic txhaj, intracutaneous) |
| WRAS Kev Pom Zoo | Cov Txheej Txheem Qhia Txog Dej (UK) | Kev sib cuag nrog dej | Tsis yog -toxicity, saj/odor test, microbiological growth inhibition |
| KTW Approval | Lub teb chaws Yelemees (dej haus) | Cov dej haus hauv lub teb chaws Yelemees | Kev kuaj kev tsiv teb tsaws chaw, kev xav tau microbiological, kuaj organoleptic |
| ACS Certification | ANSES (Fabkis) | Haus dej tiv tauj Fabkis | Cov ntawv tshaj tawm, kev txheeb xyuas kev tsiv teb tsaws, kev ntsuas kev xav |
Kev Paub Txog Kev Lag Luam:Ntau lub tuam txhab ua zaub mov xav tau ntau daim ntawv pov thawj. Piv txwv li, lub brewery tej zaum yuav xav tau FDA ua raws li kev ua lag luam (Tebchaws Asmeskas), EU Txoj Cai Tswjhwm Saib Xyuas Kev Ua Lag Luam (kev ua lag luam xa tawm), NSF 51 ntawv pov thawj (kev tswj hwm txoj cai), thiab 3-A Sanitary Standards (kev ua lag luam zoo tshaj plaws). Npaj rau 6-12 lub hlis thiab $ 15,000- $ 50,000 hauv cov nqi kuaj kom ua tiav ntau daim ntawv pov thawj kev lag luam.
7. Kev Ua Raws Li Kev Ua Tsis Taus thiab Yuav Ua Li Cas Kom Zam Lawv
Sab saum toj 10 Txoj Cai Lij Choj Hauv Khoom Noj - Qib Gaskets
Ua Tsis Tau #1: Siv Tsis yog -Colorants ua raws
Teeb meem:Dub EPDM gaskets hauv cov khoom siv ua zaub mov ua tsis tiav FDA tshuaj xyuas vim tias cov xim dub tsis nyob hauv FDA daim ntawv teev npe rau daim ntawv thov zaub mov.
Keeb kwm:Tus kws ua haujlwm tau teev cov qauv dub EPDM (feem ntau siv hauv kev siv tsheb) yam tsis tau txheeb xyuas cov zaub mov - qib xim xim.
Qhov tshwm sim:$ 180,000 nyob rau hauv cov khoom siv downtime, ua tiav gasket hloov thoob 12 ua kab, FDA ceeb toom tsab ntawv.
Kev Tiv Thaiv:
- Qhia meej "FDA-raws li dawb EPDM" kom meej meej hauv kev yuav khoom
- Yog tias muaj xim gaskets xav tau, xyuas cov xim yog FDA 21 CFR 178.3297 pom zoo
- Thov pigment specifications los ntawm tus neeg muag khoom
- Dawb, pob tshab, lossis xim ntuj yog qhov kev xaiv zoo tshaj plaws rau kev sib cuag zaub mov
Ua Tsis Tau #2: Cov ntaub ntawv xeem dhau los lossis ploj lawm
Teeb meem:Silicone gasket tus neeg muag khoom tau muab daim ntawv pov thawj FDA ua raws, tab sis cov ntawv tshaj tawm kev xeem tau muaj 5 xyoos. Thaum lub sij hawm soj ntsuam cov neeg siv khoom, kev ua raws cai tsis tuaj yeem txheeb xyuas rau kev tsim khoom tam sim no.
Keeb kwm:Tsis muaj txoj cai rau kev rov ntsuam xyuas ib ntus; tus neeg xa khoom xav tias qhov kev sim thawj zaug npog tag nrho cov khoom tsim tawm yav tom ntej.
Qhov tshwm sim:Cov neeg siv khoom yuav tsum tau rov kuaj dua tam sim ($ 3,500 tus nqi, 3 lub lis piam ua haujlwm), kev tsim khoom qeeb, poob ntawm tus neeg xa khoom nyiam.
Kev Tiv Thaiv:
- Tsim kom muaj 12-hli lub hnub nyoog siab tshaj plaws rau cov ntawv tshaj tawm kev xeem
- Rov kuaj dua thaum twg cov khoom siv raw hloov pauv
- Rov kuaj dua yog tias kev tsim khoom raug hloov kho
- Khaws lub tsev qiv ntawv xeem ntawv nrog rau kev taug qab tas sij hawm
Ua Tsis Tau #3: Cov ntaub ntawv tsis txaus ntseeg
Teeb meem:Cov xwm txheej kis kab mob hauv cov khoom noj khoom haus yuav tsum tau txheeb xyuas cov gasket batch. Chaw tsim tshuaj paus tsis tuaj yeem taug qab uas cov khoom siv raw tau siv rau hauv cov gaskets tshwj xeeb.
Keeb kwm:Batch coding system taug qab tsuas yog cov khoom tiav hnub, tsis yog cov khoom siv raw.
Qhov tshwm sim:Tsis tuaj yeem txiav txim siab qhov chaw paug; tag nrho 6-lub hlis ntau lawm rov qab; $ 2.3M hauv cov nqi; cov neeg siv khoom cog lus xaus.
Kev Tiv Thaiv:
- Siv batch coding txuas cov khoom tiav tiav rau cov khoom siv raw
- Khaws cov ntaub ntawv rau yam tsawg kawg 5 xyoos (2 xyoos tom qab lub neej khoom xav tau)
- suav nrog polymer batch, kho batch, thiab hnub tsim khoom nyob rau hauv traceability
- Ua ib xyoos rov hais dua los txheeb xyuas qhov kev ua tau zoo
Ntxiv Qhov Pitfalls
- Hla- paug thaum tsim khoom:Siv tib yam khoom siv rau FDA thiab tsis yog - cov ntaub ntawv FDA yam tsis muaj kev kuaj xyuas kom raug
- Pwm tso tus neeg sawv cev tsis yog- ua raws:Siv cov tshuaj silicone rau ntawm FDA gaskets uas tawm tsis tau - pom zoo residue
- Packing khoom contamination:Khaws FDA gaskets rau hauv lub hnab uas tsis yog - pom zoo plasticizers uas tsiv mus rau gasket nto
- Temperature specification yuam kev:Kev lees paub FDA ua raws tab sis tsis kuaj ntawm qhov siv tiag tiag (piv txwv li, chav ua kom tsis muaj menyuam ntawm 121 degree)
- Tsis meej pem "feem ntau lees paub tias muaj kev nyab xeeb" (GRAS) nrog kev ua raws li tag nrho:GRAS xwm txheej ib leeg tsis lav FDA 177.2600 ua raws
