Miyezo yamakampani a mkaka wamapaipi oyera

GMP (Good Manufacturing practice for milk Products, Good Production Practice for Dairy Products) ndiye chidule cha Dairy Production Quality Management Practice ndipo ndi njira yotsogola komanso yasayansi yopangira mkaka. Mu chaputala cha GMP, zofunikira zimayikidwa patsogolo pa zida ndi mapangidwe a mapaipi oyera, ndiye kuti, "Zida zolumikizana mwachindunji ndi mkaka ziyenera kukhala zosalala komanso zopanda mano kapena ming'alu kuti muchepetse kuchuluka kwa zinyalala zazakudya, dothi ndi zinthu zachilengedwe" , "Zida zonse zopangira ziyenera kupangidwa kuti zitsukidwe mosavuta komanso kupha tizilombo toyambitsa matenda komanso kuti tiziwona mosavuta." Mapaipi oyera amakhala ndi machitidwe odziyimira pawokha komanso ukatswiri wamphamvu. Choncho, nkhaniyi ikufotokoza za kusankha zipangizo ukhondo mapaipi, zofunika padziko kukhudzana ndi mkaka, payipi amafuna dongosolo kuwotcherera, kudzikonda kukhetsa kamangidwe, etc., cholinga kupititsa patsogolo mabizinesi mkaka ndi kumanga Chigawo kumvetsa kufunika kwa payipi woyera. unsembe ndi chithandizo.

 Ngakhale GMP imayika patsogolo zofunikira pazida ndi kapangidwe ka mapaipi oyera, zida zolemetsa ndi mapaipi opepuka ndizofala kwambiri m'makampani aku China. Monga gawo lofunikira la njira yopangira mkaka, njira zoyeretsera mapaipi akadali ndi chidwi chochepa. Sikokwanira ndi ulalo wofooka womwe umalepheretsa kuwongolera kwa mkaka. Poyerekeza ndi miyezo yoyenera yamakampani a mkaka wakunja, pali malo ambiri oti asinthe. Pakalipano, miyezo yaukhondo ya American 3-A ndi European Hygienic Engineering Design Organisation (EHEDG) imagwiritsidwa ntchito kwambiri pamakampani a mkaka wakunja. Nthawi yomweyo, mafakitale a mkaka omwe ali pansi pa Gulu la Wyeth ku United States omwe amaumirira kupanga fakitale yamkaka yomwe imakwaniritsa miyezo yamankhwala atengera mulingo wa ASME BPE ngati chitsogozo pakupanga ndi kukhazikitsa zida ndi mapaipi a fakitale yamkaka, zomwe zidzateronso. kufotokozedwa pansipa.

01

Miyezo yaumoyo ya US 3-A

Muyezo waku America 3-A ndiwodziwika komanso wofunikira padziko lonse lapansi waumoyo, wokhazikitsidwa ndi American 3-A Health Standards Company. American 3A Sanitary Standards Corporation ndi bungwe lopanda phindu lomwe lidadzipereka kulimbikitsa ukhondo wa zida zopangira chakudya, zida zopangira zakumwa, zida zamkaka ndi zida zamakampani opanga mankhwala, zomwe makamaka zimalimbikitsa chitetezo cha chakudya komanso chitetezo cha anthu.

Kampani ya 3-A Hygiene Standards Company inakonzedwa pamodzi ndi mabungwe asanu osiyanasiyana ku United States: American Dairy Producers Association (ADPI), International Federation of Food Industry Suppliers (IAFIS), ndi International Federation for Food Sanitation Protection (IAFP) , International Dairy Products Federation (IDFA), ndi 3-A Sanitary Standards Marking Council. Utsogoleri wa 3A ukuphatikiza US Food and Drug Administration (FDA), US department of Agriculture (USDA), ndi 3-A Steering Committee.

Muyezo waukhondo waku US 3-A uli ndi malamulo okhwima kwambiri pamapaipi aukhondo, monga muyeso wa 63-03 wazopaka mapaipi aukhondo:

(1) Gawo la C1.1, zopangira mapaipi okhudzana ndi mkaka ziyenera kupangidwa ndi AISI300 mndandanda wazitsulo zosapanga dzimbiri, zomwe sizingawonongeke, zopanda poizoni ndipo sizingasunthire zinthu kukhala mkaka.

(2) Ndime D1.1, pamwamba roughness Ra mtengo zosapanga dzimbiri zitsulo chitoliro zovekera kukhudzana ndi mkaka sayenera kukhala wamkulu kuposa 0,8um, ndi akufa ngodya, mabowo, mipata, etc. ayenera kupewa.

(3) Ndime D2.1, kuwotcherera pamwamba zitsulo zosapanga dzimbiri pokhudzana ndi mkaka ayenera msoko welded, ndi roughness Ra mtengo wa kuwotcherera pamwamba sayenera kukhala wamkulu kuposa 0,8um.

(4) Ndime D4.1, zopangira mapaipi ndi malo okhudzana ndi mkaka ziyenera kudzipukutira zokha zikayikidwa bwino.

02

EHEDG Hygienic Design Standard for Food Machinery

European Hygienic Engineering & Design Group European Hygiene Engineering Design Group (EHEDG). EHEDG idakhazikitsidwa mu 1989, ndi mgwirizano wa opanga zida, makampani azakudya, ndi mabungwe azaumoyo. Cholinga chake chachikulu ndikukhazikitsa miyezo yapamwamba yaukhondo pamakampani opanga zakudya ndi zonyamula.

EHEDG imayang'ana zida zopangira chakudya zomwe ziyenera kukhala ndi kapangidwe kabwino kaukhondo komanso kukhala kosavuta kuyeretsa kuti tipewe kuipitsidwa ndi tizilombo. Choncho, zipangizozo ziyenera kukhala zosavuta kuyeretsa ndi kuteteza mankhwala kuti asaipitsidwe.

Mu EHEDG "Sanitary Equipment Design Guidelines 2004 Second Edition", dongosolo la mapaipi likufotokozedwa motere:

(1) Gawo 4.1 nthawi zambiri liyenera kugwiritsa ntchito chitsulo chosapanga dzimbiri chopanda dzimbiri;

(2) Pamene pH mtengo wa mankhwala mu Gawo 4.3 uli pakati pa 6.5-8, ndende ya chloride sichidutsa 50ppm, ndipo kutentha sikudutsa 25 ° C, AISI304 chitsulo chosapanga dzimbiri kapena AISI304L chitsulo chochepa cha carbon chomwe chimakhala chosavuta kuwotcherera. kawirikawiri amasankhidwa; Ngati chloride ndende Ngati iposa 100ppm ndipo kutentha kwa ntchito kuli kopitilira 50 ℃, zida zokhala ndi dzimbiri zolimba ziyenera kugwiritsidwa ntchito kukana kutsekereza ndi kuwononga dzimbiri chifukwa cha ayoni a kloride, potero kupewa zotsalira za chlorine, monga AISI316 zitsulo zosapanga dzimbiri, komanso zotsika. carbon steel. AISI316L ili ndi ntchito yabwino yowotcherera ndipo ndiyoyenera pamapaipi.

(3) Pakatikati pa makina a mapaipi mu Gawo 6.4 ayenera kukhala odzipangira okha komanso osavuta kuyeretsa. Malo opingasa sayenera kupewedwa, ndipo mbali yopendekerayo iyenera kupangidwa kuti asawunjike madzi otsalira.

(4) Pamalo olumikizana ndi zinthu mu Gawo 6.6, cholumikizira chowotcherera chiyenera kukhala chosasunthika komanso chosalala komanso chosalala. Panthawi yowotcherera, chitetezo cha gasi cha inert chiyenera kugwiritsidwa ntchito mkati ndi kunja kwa mgwirizano kuti tipewe okosijeni wazitsulo chifukwa cha kutentha kwakukulu. Kwa kachitidwe ka mapaipi, ngati mikhalidwe yomanga (monga kukula kwa danga kapena malo ogwirira ntchito) ikuloleza, tikulimbikitsidwa kugwiritsa ntchito kuwotcherera kwa orbital momwe ndingathere, zomwe zimatha kuwongolera magawo azowotcherera ndi mtundu wa weld.

03

American ASME BPE muyezo

ASME BPE (American Society of mechanical engineers, Bio Processing Equipment) ndi mulingo wopangidwa ndi American Society of Mechanical Engineers kuti aziwongolera mapangidwe, zida, kupanga, kuyang'anira ndi kuyesa zida ndi mapaipi opangira bioprocessing ndi zida zake zothandizira.

Muyezowu udasindikizidwa koyamba mu 1997 kuti ukwaniritse miyezo yofananira komanso milingo yovomerezeka ya zida zopangira zomwe zimagwiritsidwa ntchito pamakampani a biopharmaceutical. Monga muyezo wapadziko lonse lapansi, ASME BPE imagwirizana kwathunthu ndi malamulo ndi malamulo oyenera a GMP ya dziko langa ndi US FDA. Ndilofunikira lomwe limagwiritsidwa ntchito ndi FDA kuti liwonetsetse kupanga. Ndi mulingo wofunikira kwa opanga zida ndi zida, ogulitsa, makampani opanga uinjiniya ndi ogwiritsa ntchito zida. Mulingo wosafunikira womwe umathandizidwa limodzi ndikupangidwa ndikuwunikiridwa nthawi ndi nthawi.

3-A, EHEDG, ASME BPE zizindikiro zovomerezeka zaumoyo

Pofuna kuwonetsetsa kupanga zinthu zoyera kwambiri ndikuchepetsa kuipitsidwa kwazinthu, mulingo wa ASME BPE uli ndi kufotokozera kwaukadaulo wowotcherera. Mwachitsanzo, mtundu wa 2016 uli ndi izi:

(1) SD-4.3.1 (b) Pamene mapaipi azitsulo zosapanga dzimbiri amagwiritsidwa ntchito, zinthu za 304L kapena 316L zimasankhidwa nthawi zambiri. Automatic orbital kuwotcherera ndi njira yabwino yolumikizira chitoliro. Mu chipinda choyera, zigawo za chitoliro zimapangidwa ndi 304L kapena 316L zakuthupi. Mwiniwake, womanga ndi wopanga ayenera kukwaniritsa mgwirizano pa njira yolumikizira chitoliro, mlingo woyendera ndi kuvomereza miyezo isanayambe.

(2) MJ-3.4 mapaipi kuwotcherera pomanga ayenera kugwiritsa ntchito kuwotcherera orbital basi, pokhapokha kukula kapena malo salola izo. Pankhaniyi, kuwotcherera dzanja kungathe kuchitidwa, koma ndi chilolezo cha mwiniwake kapena kontrakitala.

(3) MJ-9.6.3.2 Pambuyo kuwotcherera basi, osachepera 20% ya mikanda yowotcherera mkati iyenera kuyang'aniridwa mwachisawawa ndi endoscope. Ngati mkanda uliwonse wosayenerera wowotcherera ukuwonekera poyang'anira kuwotcherera, kuwunika kowonjezera kuyenera kuchitidwa molingana ndi zofunikira zomwe zafotokozedwazo mpaka zitavomerezeka.

04

Kugwiritsa ntchito miyezo yamakampani a mkaka wapadziko lonse lapansi

Mulingo waukhondo wa 3-A udabadwa m'ma 1920s ndipo ndi mulingo wapadziko lonse lapansi womwe umagwiritsidwa ntchito kuyika zida zaukhondo zamakampani amkaka. Chiyambireni chitukuko chake, pafupifupi makampani onse a mkaka, makampani opanga uinjiniya, opanga zida, ndi othandizira ku North America adagwiritsa ntchito. Amavomerezedwanso m'madera ena a dziko lapansi. Makampani atha kulembetsa chiphaso cha 3-A cha mapaipi, zopangira mapaipi, mavavu, mapampu ndi zida zina zaukhondo. 3-A ikonza owunika kuti aziyesa zoyesa patsamba ndikuwunika mabizinesi, ndikupereka satifiketi yaumoyo ya 3A akamaliza kuunikanso.

Ngakhale muyezo waumoyo wa EHEDG waku Europe unayamba mochedwa kuposa muyezo wa US 3-A, wakula mwachangu. Kachitidwe kake ka certification ndizovuta kwambiri kuposa muyezo wa US 3-A. Kampani yopemphayo iyenera kutumiza zida zotsimikizira ku labotale yapadera yoyesera ku Europe kuti ikayesedwe. Mwachitsanzo, poyesa mpope wa centrifugal, pokhapokha atatsimikiza kuti luso lodziyeretsa la mpope ndilocheperapo kuposa luso lodzitchinjiriza la payipi yowongoka, ndiye kuti chizindikiritso cha EHEDG chingapezeke. nthawi yodziwika.

Muyezo wa ASME BPE uli ndi mbiri ya zaka pafupifupi 20 kuchokera pamene unakhazikitsidwa mu 1997. Amagwiritsidwa ntchito pafupifupi m'makampani onse akuluakulu a biopharmaceutical ndi makampani a engineering, opanga zipangizo, ndi othandizira. M'makampani a mkaka, Wyeth, monga kampani ya Fortune 500, mafakitale ake a mkaka atengera miyezo ya ASME BPE monga chitsogozo pakupanga ndi kukhazikitsa zida ndi mapaipi a fakitale ya mkaka. Iwo adatengera malingaliro owongolera opanga mafakitale opanga mankhwala ndipo adatengera ukadaulo wowotcherera wodziwikiratu kuti apange mzere wapamwamba wopanga mkaka.

Ukadaulo wowotcherera wokha umapangitsa kuti mkaka ukhale wabwino

Masiku ano, pamene dziko likuyang'anitsitsa chitetezo cha chakudya, chitetezo cha mkaka chakhala chofunika kwambiri. Monga wogulitsa zida za fakitale ya mkaka, ndi udindo ndi udindo wopereka zipangizo zamakono ndi zipangizo zomwe zimathandiza kuonetsetsa kuti mkaka umakhala wabwino.

Makina owotcherera ukadaulo amatha kuwonetsetsa kugwirizana kwa kuwotcherera popanda kutengera zinthu zamunthu, ndipo magawo a njira yowotcherera monga mtunda wa ndodo ya tungsten, liwiro lapano, ndi liwiro lozungulira ndizokhazikika. magawo Programmable ndi kujambula basi kuwotcherera magawo n'zosavuta kukwaniritsa zofunika muyezo ndipo dzuwa kupanga kuwotcherera ndi mkulu. Monga momwe chithunzi 3, mapaipi amamasulira pambuyo kuwotcherera basi.

Kupindula ndi chimodzi mwazinthu zomwe wochita bizinesi wamakampani a mkaka ayenera kuziganizira. Kupyolera mu kusanthula mtengo, zikuwoneka kuti kugwiritsa ntchito luso kuwotcherera basi kumangofunika kampani yomanga kuti ikhale ndi makina owotcherera okha, koma mtengo wonse wamakampani a mkaka udzachepetsedwa kwambiri:

1. Kuchepetsa ndalama zogwirira ntchito zowotcherera mapaipi;

2. Chifukwa mikanda yowotcherera ndi yofananira komanso yowoneka bwino, ndipo sikophweka kupanga ngodya zakufa, mtengo watsiku ndi tsiku wa kuyeretsa CIP umachepetsa;

3. Chiwopsezo cha chitetezo cha kuwotcherera pamapaipi amachepetsedwa kwambiri, ndipo mtengo wachitetezo wamkaka wabizinesi umachepetsedwa kwambiri;

4. Kuwotcherera kwa kayendedwe ka mapaipi ndi odalirika, ubwino wa mkaka umatsimikiziridwa, ndipo mtengo wa kuyezetsa mankhwala ndi kuyezetsa mapaipi wachepetsedwa.