Bais BAO Bi VA TUOI THO (PACKAGING MATERIALS AND SHELF-LIFE) MUC TIEU BAL GIANG 1.” Ké ten mgt sé ogi bao bi duge ding trong neanh Dug 2. Trinh by duge tam quan rong ea bao bi an hong dnt tho cua thud DAN BAL 1. Dai cuong 2. Bao bi bing chat déo 3. Bao bi bang thuy tinh 4. Nip dy 5, Bao bi bing kim fou Két lun NOLDUNG: 1.DAL CUONG Noi chung thude bao gbm mt hay nhigu duge chit duge bao ehé thanh ede dang dye phim ‘hich hop. Trude khi dura vao hau thing thude phai duge dmg trong nhdmg bao bi thich hop, Ba b phan c6 quan hg true tigp ken dp bén ving cua thude Ia Durye pham- Bao bi - Mot trum Boo bi 1a dung eu diing d2 dyng duge phim. tre tip tigi sue véi duge phim. Do vas bi 66 thé e6 nhing anh hudng mht dinhtich ete hay tigu eye len elt lugng duge phim ‘Thong que bao bi. duige phim o6 thé chiu tae ng cun d5 am, cua oxygen tir khdng khi cua mi trudmg bén ngodi thi qua bao bi. Anh sing chigu xuyén qua bao bi edng 66 thé din dén sy héa phan, quang phan cia duge chit, Cie due pham kha e6 xu husng bi be hoi nhur eb thude va thude nue néw hur dymg bao bi Khdng kin. Khing chi cée dui h ma ca cae thude rita vet thuong (lotion) va cae ke duce dug trong cée bao bi thich hop. Chi e6 vige thing qua sy Iva chon vt ligu bao bi thich hop moi thoa man tuéi tho cua thude trong bao bi. Cé thé nd ing digu kign vi khi hu thich hp nhit cho tu6i tho phi due dim bao ngay bén trong bao bi Ban than bao bi eding chiu nhimg thay di do khi hiu way ra, Tudi thy cua bao bi phai duge quan tm truse tiga so v6 thude chia trong dé. Hon nda bao bi pha tro vi thude dum bén trong. Do vay bao bi phai Khing durge phing thich ede chit la. vo thude hay hip thu cdc eh viethade Tit nhign o6 nhomg yéu edu tuygt dbi duge thy hign theo ede ddi hoi cua thye nghigm. Vige bao v@ Khoi cde anh hucmg bén ngodi Khong phat li tét ea nhimg dO; hoi v€ tinh ter pha nghiém ngat cho mt chun mire duge xp vio d@ an toan khong gay i cho thude Vige Iya chon bao bi c6 dking vé rigng bigt pha duge dn gi lin lu e6 quan hg vi tdi tho cila thude mét cach toan dign. Trong quid tin phat trign eda ché phim mi. pha duge tig han th dé khao sit céng tire thich hop nt va third term), Se rit tn kém dé i hie thube néu tt ea bao bi lain phién duge bao. cic dung dich e« n cng bj hu hong néu nhue khong ge lua chon va thir nghigm thich hop bao bi i han (long‘ing"voi khodng ky han sém nhat. D6 la ly do tai sao ta thudng ha ding phurong php wi hoa cap tbe (accelerated testing). Cae eo si Khie la ning higu bigt ve Iy va hoa tinh cua thude durge quan tim trong qué trinh xy: dung edng thite thube va thye righigm chung. Do vay Iva chon vat ligu cua bao bi ka mt de trung dy dosin ding ké vi phat niin bing thoi han dai (long teem). Néu thade khing bén ede thir nghigm_phai duge tién hanh dé xée nbn nguyén nhin nén kién thie vé_thude phai ludn ludn duge ep nat. Nhiing thuat ngirthudng duge ding theo tinh chat cia bao bi ~ Bao bi don lieu (single dose container) - Bao bi da ligu (multidose container) - Bao bi dng kin (well-closed container) ~ Bao bi chéng thm (airtight container) - Bao bi han kin (sealed container) Hai loai bao bi dong kin va bao bi chéng thim hay duge ding. Bao bi ding kin dé bio ve duge pham khi tiép xc voi mai trudng va cate vat thé bén ngoai trinh cho duge phim khong bj mat hoat fue trong qu trinh tin trt vd luu thong. Bao bi chéng thim git cho sin phim Khoi bj 6 nhigm tu moi trudng bén ngoai . Khéng bj hat im, Khong bj déng von hay dong cimg. khéng bi chay nude hay bay hoi va Khong kam mt higu lye eda thude. Khi duge phim duge dung trong bao bi e6 ghi 14 déng kin hay chéng thm can phai tién hanh thir nehigm cat chi tgu nay kh kigm ta eit leon cua bao bid ya chon, 2.BAO Bi BANG CHAT DEO Chit deo (Plastic) la vt lgu dug sir dung kha pho Vat ligu duye sir dung lam bao bi bing chat deo: PLE (Polyethylen) PSS (Polystyren) P.V.C(Polyviny| clorid) PLP. (Polypropylen) C6 rit nhigu yéu t5 anh huang dén tinh twong thich cia chat deo khi duge st dung trong edng nghigp duge: thinh phin, qui rude tigp vic. mye in, chat kEt din, tinh thdm caa phy gia. Cae thir nghigm duge tén hanh v6i chit do: % This nghigm ly hoe: chi s6 chay. diém hoa mém., 46 ecing. 4 rong. phd IR. chi sé khvie xe Thirnghigm vé anh hurong cua chat déo v6i chit chia bén trong: cin khong bay hoi, cn sau khi nung, kim loai nding. kha nang dgm, chat ehigt duge bin «49 trayén quang. ‘Thur nghigm sinh hoe: tinh thich hop ding dmg thude tigm (dich truyén). ding cho dling lim ti dyng mau, ding lam ede vi Tigu y Khoa khée, cht tigu sau clin phai kigm tra nhu: d@ ro ri. d khang bgt, d6 trong. tie dng huyét wii eh nhigtt8, de tinh bat thug, & Tinh thm cua chai dung bing chat déo 1 dug cudi duge xé én dé lam bao bi cho duge phimDidu edn dae bigt uu y la tinh thim hai chigu cua chit déo nghia la hoi nude, Khong Khi, COs vi O> 66 thé thm qua thinh chit déo anh hisémy dén thude bén trong vt nguge lai. Sy Khao sét chi tiét vé tinh thdm duge minh hoa bang cae bigu dd sau: Hinh 1: minh hoa théng ké vé sy that thoat do bay hoi cia cae chai riéng bigt 66 chira dung dich cn dumg trong nhém chai ding nhdt bing polyethylen e6 khdi lrgng riéng lin duge d3t G nhigt d6 20-25°C trong khoang thai gian 801 ngay, Trong bigu d xét vé ting thé sq that thoat do thm qua thinh va bay hoi fa gin nhur nhau déi vai da s6 cde chai, MOt vai ngogi If 66 sy that thodt lon 1a do sw vi ran mit cua chai Khon phat hign ngay durge bang phuong phap thir d@ kin thong thutng va chi tée dng trong khoang thai gian vai thang. Hin |: Théng ké vé sy that thoat do bay hoi ctia ede chat ri Hinh 2 minh hoa sy that théat do bay hoi cua dung dich cOn trong eae chai bing chat deo diy kin va duge dat trong chan khong. Bigu d5 43 duge vé vi su try witip cua mot plotter (may v8 48 thi) sau mi lin nhdp s6 ligu. Chuong trinh” follow-up" duge si dyng 48 tinh todn gid tri trung binh sé hoe va gid tr trung vi (median) va trinh bay ede gid tri nay trong 48 thi trong Khosing tr 25-75% ham longHHinh 3 minh hoa duce ghi lai theo thoi gian thir. Tée d9 tang eva trung chinh [gi sw vuot tri trong thoi gian kéo dai. Tinh thi qua thanh da 66 sys hong teim trong no trong ede binh duge dy Kin xy ra. C ya vo sy thirnghigm miu thir tn tri rong digw kign binh thudng, inh bj mit di do bay hoi. Trung vi wf tr eve dv eve Hu ge hoa min v8 tinh dng nhit va hong thay di. Khon bigu dd thudng duge inh 3: Bidu dign gid tr rung binh bj mat di do bay hot 3. BAO Bi BANG THUY TINH Dé nan ngia kha nding thm cua bao bi nén diing vat tao bi truyén théng duge sir dung rong ri nht vi dam bio duge tinh tr tinh trong su6t ih wing chic, d6 eimmg. ching dm, d& dng kin va ni vinh kink, Mt sd ogi thy tinh 66 rihuge diém 14 sau mt thoi gian bao quan ¢6 thé bj thoi kiém vi bj loc thuy tinh anh huong dén chit lugng thude “Theo USP - 22 thay tinh ding Kam bao bi chia kim 4 loa thiy tinh trung tinh 6 a kigm thdp nh (Highly resistant borosfieat) tun -m Hydrolyte resistance ~ USP [Lgai It fog thy tinh dd dug sid Yai kif (Treated sodatime glass), Ci hai fea v8 11 déu ding dé dng thude tiém ‘Loai HI: 4 loai thuy tinh thong. khong ding dé dong thude tiém (trir khi thir nghiém bin ving chi Khng anh hurdng dn cht hngng thud). Loai NP: diing cho bao bi thuée udng va thade ding ngoat ‘Thanh phin thay tinh duge cho theo bang ds dy 746 46 | 0 | 63oy Hinh 4; Buiing cong hap thy eta nhiéu foal thuy tinh Dé th) dudng cong hap thu eaia nhiéw loai thay tinh nu (niu sim. naw nhgt) duuge Khao st fa vin cn dur mot lung nh sing di qua duge nim 6 trong vane e6 hat tinh quang hoa (340- 370nm) va digu nay eng duge cde duge dign chip nhan do dung sai (USP XX1 ; Ths 10%6). LLy-do thay tinh hod toan hap thy o ving nay s® Khong da trong cain thigt dé kigm trae phan la c6 trong dung dich ding udng (D9 trong). Dit cho da ding thay tinh maw Toai | vin thigt phai co thém nan phu: “Bio quiin chéng énh sing”. Vige kéo dai han diing do duge siphan phi bac si ké don hay bénh nhan la khong thé duye chip nhin ngay ca véi thy tn nau chi ehiin durge bao v@ hoan toan v6i dn sing. tiéu ‘Trong khi da sé ede duge dién chi md ta mau sie eta thay tinh bing ce thudt ngir chung. Duge dién Nhét va Dai han dua ra gid tr dO trong t6i thigu. Gid tr] dle tung la 600nm ngosi ca day 66 hogt tinh quang hoa. Thyc 16 wi tri t6i thiéu nay chi gap v6i thiy tinh nu nhat hay thay tinh mau mat ong. Do vay’ cée duge dign nay cing cho phép dO truyén quang cao hon cho dnh sing 6 viing e6 hogt tinh quang hoa va do vay chip nhan tic dung bao vg ching sing iam, Bigu nay khong nahi nao gt se Theo duge dign Chau Au. thuy tinh nau khOng nén di thude 66 su hudng bi mit mau. D6 la dya trén co so phai kiém tra lugmg chia bén trong bang quan sit. Thye té la sir bién déi cua mau 66 thé say ra trong qua trinh tn tr Khong c6 thé Khao sit duge chat lung, ccho cde durge si o khiu phan phdi cing nhw cho cée bac st. phOng mach vi ho khing thé €6 due nhitng chudin d6i chimg thich hop. ang theo duge dién Chau Au thay tinh nau chi ding trong ede dung dieh thude qua nhay voi ainh sang, Thuat ng “eye nhay voi anh sing hua duge xée dinh mét eich dge higu dieu nay cdng Khong thgt edn thigt. Mot eBng thie thuée khong thé xép vo logi qué nhay eam voi anh sing néu nur chi bj hong khi cho tiép xi ‘v6i inh sing vai gity v6i cutmg d9 sing 600 lux. Bigu ndy tuong duomg v6i dp sing o digu kign lam vige binh thug Khi cdin phai tigp sic vii dinh sing ¢6 eutmg d6 eao nén thém bao bi phy bing ede hip bao rngbai dé bao vé cho cée ché phim qua nhay voi anh sing. Két hop vGi vige ding thay tinh niu, 4, NAP (NUT) DAY (STOPPERS)va ban ohdt nit duge lam bing eao sii wy nhién hay cao su ting hop. Ceo su cong nhu eée elastomers durge coi nhur vit Tigu phic tap. duge ding cing v6i thiy tinh dé cho cée dung ich tiém truyén, Nén can phai Khao sit anh hudmg eda ching [én dO bén ving eta ede dune ich thude Thong thuimy a0 su chia Kim hai logi cao su e6 Iuw hugnh va cao su khOng e6 fu hiynh. Sy phan bigt nay chu that tho dng vi e6 logi elastomer durae eho them phy gia e6 law hus nh ‘B6i voi cao su ty nhign lau hugnh dong vai te Iuw hoa nén goi fa tie nh luw héa. Nhu vay 6 mét sb chites thé tan 6 mize d} nfo d6 vo nude lam anh hurdng 161-69 bn vimg cia thude. Nhu dai biét cde hop chét co Iw hujnh tham gia vao rét nhidu tuong td. Nhiing diéu nay khong chi rigng cho cée eao su tyr nhign ngay cho ea cao su tong hyp nhs cao su nitrile va buty! néi chéo cling diing cdc tae nhan tang tbe (accelerators). Neue lai loai cao su halobuty! hign dai Iai khéng edn dén cde phy gia nhur vay. sy lién két eho xay ra khong sir dung dén lwu hujnh va sy hoat héa duwge thye hign bai km oxide va magnesie oxide. ede oxide nay duge str dyng thay cho cae chat lun héa qui ue. Higu qua duong tinh cia sy khong, 6 mat fuu hugh va ede chat tang tée khée Ia hiém thy ede hop chit h6a hoe tim thay trong, dich chiét tr phép thir ndi hdp hay ding cia cao su halobutyl 8 thir nghigm Iugng chet phong thich do chit, tién hanh nur sau tong dign tich khong 100em? ding 200m! nusic ding tiém rua fen phan cao sum chai bing phuung tign thich hop. Sau d6 tin heanh hap tigt tring. Sau khi fam ngudi dich eh nude durge dé King va tién hanb céc thir nghigm theo bang dui. Bangi kr két qua phn tic thu diegetit hai loal uo sn, a Cao su te nhién diese ew 6a vii heu hyn’ by Cao su tang hop chlorobuy! kh c6 lia hin Nhain xét © Trong inpdne hap lieu hia: bing plarong phip thang thrdng x8 phir hien mt tuong dang ke chat khit. Gid tri néy dire xée dink bing sé ml KMnOs diege tiéw thy bang plug phip chun dé. Them vio dé etn phat hign mot long can kho chat khong ba hot va hap thy UV. Neuoe lai new 1 halobutyl cde chi tiéu tren gain nine bing (Chemical safety Berlin 14.12.7007 0781 a TEST-no a) 838/8 b) V1345 IDescription: Infusion st6ppeF= a) Red ‘Supplier: A B (Designation: 3 ‘Material identification: a) natural rubber. containing sulphur b) chlorobutylruber. sulphur-free [Results of tests according to Pharm. Lab, Spec. M6/DIN 58367 Shore hardness: a)48 b}#9 Vol. Sulphides: a) negative b) negative [Ash content: a) 32% b) 3.7% [Extraction test: (3 samples/200ml water 30min. 121°C ‘Shore hardness: a8 b}49 Vol. Sulphides: a) negative _b) neyative ‘Sample a)Resut ib) Requirement [Description unchanged “unchanged dy 3 nit dich by black unchanged ‘unchany4 02 Mno Bang trén minh hoa thanh phan dign hinh cua thiy tinh. Thiiy tinh e6 thé coi nhy san phim. do nung chay acid silicic va cde oxid kim logi ri Kim ngudi di Trong thay tinh ogi | ¢6 mt ty cao cia B vi Al hon léthuy tinh kiém thing thuémg, Do d6 sr thoi kiém cua thay tinh loaf gidm ding ké. Con thay tinh foai I! hoain toa kha . Trong qua trinh tdi uy8n thiy tinh (Treated soda lime) kiém va kiém tho bi chit tach, Mot Kip mong cia thiy tinh thach anh c6n Iai do vay thuy tink Logi nay eo muted thap ede thin phin hdc. Lip mang nay’ e6 thé bj phi hy bing ee dung dich kiém. Trong ning trudng hyp die bigt nghia la v6i cée dung dich wiau ion Na* mu sy fi dp thy ion Na° e6 thé say ra. Khi lip ming méng niy bi phé hity Iai cho phép kigm c6 thé Khuyéch tin tr ede lop bén trong thuy tinh ra dung dich dumg diy vao chai Tir bang trén cho thay kigu thuy tinh logi I khéng phite tap. Nhung lai c6 nhimg tén that kha Thy tinh loai I duge de trang bing d6 thoi kigm tha khi khOng bi qué nng. Khi thay tinh ‘e6 dang éng va dic big i Ip thube tim e6 thé ti thay tinh két de. Sy Ket de nay giai phong mot lugng kiém ding ké, Luong kiém o6 thé thay di tr Sng tigm nay sang dng tigm khée. Do ‘vay d6i v6i ede thir nghigm Lau dai ef pha eh ¥ dn kha nang nay. Digu may etng ly wii ve syrkhienhau vé pH cua cée éng tim rigng big. Cie thinh phin eta thiy tinh duge chia thanh cde thanh phan thay d6i duge va ede than phiin thay di it. Cae chat kigm .”kidm thd thuge v8 nhm thif nhét-ede thanh phan thay thé duge con nhém thir hai bao gém khong chi Bo. Al ma ca Fe va Mn, Thanh phan sau nay Fe Mn la 0 nén thy tinh nau, Neay ea dud diéu kign te dng man cc fon sit higm bj teh ra Khoi thay tinh niu, trong cae digu hign binh thudng edn Khing gay’ ra nguy hai cho d6 bén ‘ing cia ede dung dich thude. Mat Khic cing e6 thé cho thém vao dung dich thude ede tie hain tgo phise dé khéa ede kim logi nding c6 tée dung xic te Iai bao vg tinh bén ving cia tie nihan hogt tinh Vai bao bi thay tinh thuing phi ehd § 164 kha nang chéng nh sing cua thay tinh, Troy cng tae bao quan duge phim yéu edu cua digu kign :" DE NOL KHO MAT TRANH ANH SANG" hay nhin phy c6 ghi “STORE PROTECTED TROM LIGHT Hinh 4 minh hoa sy phy thude cua d® théu quang eva thy tinh theo burée sé chigu 6 ‘ia anh iNip day cing la mot phan ciia hg théng dd bao goi edn durge nghign city trong. vai tr tham duge phan img ly h6a voi ch ci chat Khe tia vo dO ben ving cia thude mBt eich tin dign. Nip daykho hogt chit chit bén trong. khong duge hap thy sin phim cling nhur ph vio san phim. Nap day cin duge van bing momen xo tuong dong véi momen xodn khi ma bing tay cia noudi su dung. Khi nghign eiru vé do bén vitng phai thye hign trén bao bi thuong phim eo ‘momen soin cia nip dy gidng nhur momen xodn khi san xuat, Cée chit lyophilisates thug hit im et manh va ki ngudn ge tim tang him Iuiong nue trong qui trinh tm tr do vay ai cng phai Khao sit vt ligu lam nap day. Vige thir nghigm duge tién hanh bing phép do cu lény (Coulometry) him lugng nude duge phéng thich ra tir nit 180°C trong dong Khi nitrogen da duge lam kho. Hinh 5 minh hoa sy phéng thich ham lung nude boi cde nit voi cde KF thudt dong nit khic hau: ae a LSULER tomo sha theme, ae en, a8 = Hinh 5: Bidu dign sy phong thich ham luong nurde tir ede nit ~ KY thudt déng ndt khae nha Cae thir nghiém sau da due tién hanh so sinh: 1. Khiéng theo qui tinh (Unprocessed) 2. Qui trinh lam kh binh thuomg (Normal drying process) 3. Quitrinh lam khé chan khdng (Vacuum drying process) 4. Quitrnh fam khs binh thudmg (Normal drying process) 5. Quitrinh lam kh chan khéng (Vacuum drying process) 6. Kiém tra (Control) hain vet: 4 Su diy nip khé binh thyme khdng hit higu, chi c6 sy dy nip kho chan kh6ng mi e6 te dung gidm ding ké him lugng nude cia nip day. Diéu nay cho foi khuyén trong nhiing me dich de bigt én 66 ki thudt dy nip thich hop. & Bat diu him long nude duge phing thich nhanh digu nay duge giai thich 1a nude bi hip phy vao b? mat cia nit duge phong thich. Tiép sau him luamg nude phong thich giam din duye coi nhu d@ am cua chinh ty bén trong nut gidi phOng raCan phi thit nghigm di v6 cde elastomer v8 tinh thm et ching d6i vi hoi vt Khi. Cao su butyl va halobuty! co khdi lwong riéng lén la nhom e6 de tinh trdi nguege vei cao su ty nhién vi ego st téng hop isoprene. Nhém sau ny e6 téc d thm eno hom va do viy phai trinh dig cho cae ché phim dae bigt d2 bj phan hiiy. Cac chat v6i ligu thép trong dung dich thus 60 xu hurgng bj hap thy vii céc elastomer cb tinh tham cao véi khi va hoi. Diéu nay cing ap dung cho ede chit bio quan. Sy so sinh cho thiy cde ea0 su butyl vat halobutl e6 kh Luong riéng I6n it hap thy hon, Voi nhom thi ba e6 thé gay ra hign twong td két tinh khi dong diy hay’ lam day. Thi dy vige ‘wo ra barium sulphate, Sy ti két tinh nity Khong cin 16i phan img héa hoc nio, Calcium carbonate e6 thé hinh thinh ce mudi it tan v6i ede thanh phan trong dung dich thuée vi nhur ‘vy Him cho dung dich thude bj due 5. BAO Bi BANG KIM LOAIL Mat sO kim logi nur tige va nhim cing duge ding tim bao bi dung duye phim. Thing thuomg hay duge ding dusi dang dng tp (tubes), Phy thuge vio d6 acid cua ché phim dune trong éng e6 thé xay ra su va cham cua ché phim v6i thanh éng dung. CO thé c& mii cink a {ide hi phat sinh trong Sng do hu qua cia kim loi bj haa tan trong thude gay sr phan hy. Do vay thudng hay ding ede chit dé bio v¢ la cde nhya eposy hay gém lic. Sau Kh ady 'ép nhya bio vé nay gilip chong lai cde tong tae héa hoe cia thude voi twyp dung. Bigu edn /iu ¥ [a top nya bao vé nay phai due phi déu mat trong dng. Néu si pha chun déu eb the tin Ranh bang thu nghigm thing hoa (sublimat). Than éng di duge tring nba thich hyp va duge xdy kho. cho tiép xie nhanh v6i dung dich thiysngan clorid (HgCl) diém nio hua divas phu ky st suat hin hign tug ne hoa (etMorescence). Bigu my Khdng edn nghi ne vé bige tome lung 15 Ki tam d bao g6i d& thir hie an dil. Trong khuén Kho cuia hang logt thir hig vé 49 bén ving cua thube d& quan scr tay nite rene ic Diet gta kim foal eva tsp dong vs thude chiea hem rong. Qua ede ka si dp hién ra tron mdi train hep Wi do sr baw tring King it eva lip gm lc mgay a mig tne. Khon Inghi mgd gi diy chink lu quad cua ki thud tg le 6. KET LUAN Bao bi dong mot vai trd quan trong trong vige bao quan thude. DS bén ving cua thube, wéi tho ela ché phim dyng trong bao bi chiu anh hung trv tgp ei bao bi. Bao bi cing bao vé thuée ehdng Ii cée vie ding eda moi tuing. Do vay chi e6 sy nghién edu ty my’ va he thong ¥é lo bi m6 tht sy dip ing cho vig kéo ci tdi tho cua thube va dam bao duge eh lugng iia thud. TU KHOA Bao bi, bao bi bing chit déo. bao bi bing thay tinh, bao bi bg kim Iga, nip. nit day. baobi don liéu, bao bi da i kin, bao bi han kin, bao bi dong chat CAU HOLON TAP 1. Néu mot 6 logi bao bi hay duge sir dung trong nginh Daye ? 2. Cie thugt nga thudng duge diing theo tinh chit cua bao bi? 3. Néu eéc thir nghigm d6i vi bao bi biing chit déo ? 4. Cée logi bao bi thay tinh ? Nap diy ? Bao bi kim loai ?