Mehato ea ho laola boleng ba lifeme tsa meriana ea HPMC (hydroxypropyl methylcellulose) ke mokhoa oa bohlokoa oa ho netefatsa ho tsitsisa, ho hloeka le polokeho ea lihlahisoa nakong ea tlhahiso.
1. Taolo ea thepa e tala
1.1 Tlhahlobo ea bafani ba thepa e tala
Lifeme tsa meriana li hloka ho khetha barekisi ba thepa e tala ba netefalitsoeng le ho li hlahloba le ho li hlahloba khafetsa ho netefatsa botsitso ba boleng ba thepa e tala.
1.2 Tlhahlobo ea kamohelo ea thepa e tala
Sehlopha se seng le se seng sa thepa e tala se tlameha ho hlahlojoa ka thata pele se kena tšebetsong ea tlhahiso, joalo ka tlhahlobo ea chebahalo, tlhahlobo ea sebopeho sa lik'hemik'hale, qeto ea boemo ba mongobo, joalo-joalo, ho netefatsa hore li fihlella maemo a boleng.
1.3 Tlhokomelo ea boemo ba polokelo
Tikoloho ea polokelo ea lihlahisoa tse tala e laoloa ka thata, joalo ka mocheso le mongobo, ho thibela liphetoho tsa boleng nakong ea polokelo.
2. Taolo ea ts'ebetso ea tlhahiso
2.1 Ho netefatsa ts'ebetso
Ts'ebetso ea tlhahiso e tlameha ho netefatsoa ho netefatsa hore e ka hlahisa lihlahisoa ka botsitso tse fihlelang maemo a lebelletsoeng a boleng. Netefatso e kenyelletsa ho beha maemo a ts'ebetso, ho tsebahatsa le ho lekola lintlha tsa bohlokoa tsa taolo (CCP) ts'ebetsong ea tlhahiso.
2.2 Tlhokomelo ea Marang-rang
Nakong ea ts'ebetso ea tlhahiso, lisebelisoa tse tsoetseng pele tsa lisebelisoa tsa marang-rang li sebelisetsoa ho shebella litekanyetso tsa bohlokoa ka nako ea sebele, tse kang mocheso, khatello, lebelo le susumetsang, joalo-joalo, ho netefatsa hore ts'ebetso ea tlhahiso e sebetsa ka har'a mefuta e behiloeng.
2.3 Tlhahlobo ea Sehlahisoa sa Mahareng
Dihlahiswa tsa mahareng di nkwa disampole le ho hlahlojwa kgafetsa ho netefatsa hore boleng ba tsona bo dula bo tsitsitse methating yohle ya tlhahiso. Litlhahlobo tsena li kenyelletsa thepa ea 'mele le ea lik'hemik'hale joalo ka ponahalo, solubility, viscosity, boleng ba pH, jj.
3. Taolo ea Boleng ba Sehlahisoa e felile
3.1 Tlhahlobo e Feletseng ea Sehlahisoa
Sehlahisoa sa ho qetela se tlas'a tlhahlobo e pharaletseng ea boleng, ho kenyelletsa le ponahalo, thepa ea 'mele le ea lik'hemik'hale, bohloeki, lintho tse sa hloekang, joalo-joalo, ho netefatsa hore sehlahisoa se kopana le pharmacopoeia kapa litekanyetso tsa ka hare.
3.2 Teko ea Botsitso
Sehlahisoa se phethiloeng se lekoa bakeng sa botsitso ho hlahloba liphetoho tsa boleng ba sehlahisoa nakong ea polokelo. Lintho tsa liteko li kenyelletsa ponahalo, ho tšoana ha litaba, tlhahiso ea litšila, joalo-joalo.
3.3 Tlhahlobo ea Tokollo
Ka mor'a hore tlhahlobo ea sehlahisoa se phethiloeng e fumanehe, ho boetse ho hlokahala hore ho etsoe tlhahlobo ea tokollo ho netefatsa hore sehlahisoa se finyella litlhoko tsohle tsa boleng pele se rekisoa kapa se sebelisoa.
4. Thepa le Taolo ea Tikoloho
4.1 Tlhophiso ea ho Hloekisa Lisebelisoa
Lisebelisoa tsa tlhahiso li hloka ho hloekisoa le ho tšeloa likokoana-hloko khafetsa, 'me phello ea ho hloekisa e tlameha ho netefatsoa ho thibela tšoaetso. Ho netefatsa ho kenyelletsa ho lemoha masala, ho hloekisa paramethara le litlaleho tsa mekhoa ea ho hloekisa.
4.2 Tekolo ea Tikoloho
Maemo a tikoloho sebakeng sa tlhahiso a behiloe leihlo ka thata, ho kenyeletsoa bohloeki ba moea, mojaro oa likokoana-hloko, mocheso le mongobo, ho netefatsa hore tikoloho ea tlhahiso e finyella litlhoko tsa GMP (Good Manufacturing Practice).
4.3 Tlhokomelo ea Lisebelisoa le Tekanyo
Thepa ea tlhahiso e hloka ho hlokomeloa le ho lekanyetsoa khafetsa ho netefatsa ts'ebetso ea eona e tloaelehileng le ho nepahala ha litekanyo, le ho qoba ho hloleha ha lisebelisoa ho ama boleng ba sehlahisoa.
5. Koetliso le Tsamaiso ea Basebetsi
5.1 Koetliso ea Basebetsi
Basebeletsi ba tlhahiso le taolo ea boleng ba hloka ho fumana koetliso khafetsa ho tseba mekhoa ea morao-rao ea ts'ebetso, mekhoa ea taolo ea boleng le litlhoko tsa GMP ho ntlafatsa tsebo ea bona ea profeshenale le tlhokomeliso ea boleng.
5.2 Tsamaiso ea Boikarabello ba Mosebetsi
Tsamaiso ea boikarabello ba mosebetsi e kenngoa ts'ebetsong, 'me sehokelo se seng le se seng se na le motho ea inehetseng ea ikarabellang, ea hlakisang boikarabello ba bona taolong ea boleng le ho netefatsa hore mehato ea taolo ea boleng e ka kengoa ts'ebetsong ka nepo sehokelong ka seng.
5.3 Tekolo ya tshebetso
Nako le nako lekola mosebetsi oa basebetsi ba laolang boleng ho ba khothaletsa ho ntlafatsa boleng ba mosebetsi le katleho, le ho lemoha le ho lokisa mathata ts'ebetsong hanghang.
6. Tsamaiso ea litokomane
6.1 Litlaleho le litlaleho
Lintlha tsohle le liphetho tsa ts'ebetso ea taolo ea boleng li tlameha ho ngoloa 'me tlaleho e feletseng e tlameha ho thehoa bakeng sa ho hlahlojoa le ho latelloa. Lirekoto tsena li kenyelletsa kamohelo ea thepa e tala, liparamente tsa ts'ebetso ea tlhahiso, liphetho tsa tlhahlobo ea sehlahisoa se felileng, jj.
6.2 Tlhahlobo ea litokomane
Kamehla hlahloba le ho ntlafatsa litokomane tse amanang le taolo ea boleng ho netefatsa ho nepahala le nako ea litaba tsa tsona le ho qoba mathata a boleng a bakoang ke litokomane tse felloang ke nako kapa tse fosahetseng.
7. Tlhahlobo ea ka hare le tlhahlobo ea kantle
7.1 Tlhahlobo ea ka hare
Lifeme tsa meriana li hloka ho etsa tlhahlobo ea ka hare khafetsa ho lekola ts'ebetsong ea taolo ea boleng lehokelong ka leng, ho tseba le ho lokisa likotsi tse ka bang teng tsa boleng, le ho tsoela pele ho ntlafatsa tsamaiso ea boleng.
7.2 Tlhahlobo ea kantle
Amohela ho hlahlojoa khafetsa ke balaoli ba taolo ea mmuso le mekhatlo ea batho ba bang ba fanang ka setifikeiti ho netefatsa hore sistimi ea taolo ea boleng e lumellana le melao e amehang, melaoana le maemo a indasteri.
8. Tsamaiso ea tletlebo le hopola
8.1 Ho sebetsana le litletlebo
Lifeme tsa meriana li lokela ho theha mokhoa o khethehileng oa ho sebetsana le litletlebo ho bokella le ho sekaseka maikutlo a bareki ka nako, ho rarolla mathata a boleng, le ho nka mehato e tsamaellanang ea ntlafatso.
8.2 Khopotso ea sehlahisoa
Hlahisa le ho kenya ts'ebetsong mekhoa ea ho hopola lihlahisoa, 'me ha mathata a tebileng a boleng kapa likotsi tsa ts'ireletso li fumanoa lihlahisoa, li ka hopola kapele lihlahisoa tse nang le bothata' me li nka mehato e lumellanang ea tokiso.
9. Ntlafatso e tsoelang pele
9.1 Taolo ea kotsi ea boleng
Sebelisa lisebelisoa tsa taolo ea likotsi tsa boleng (joalo ka FMEA, HACCP) bakeng sa tlhahlobo le taolo ea kotsi, ho tseba le ho laola likotsi tse ka bang teng tsa boleng.
9.2 Moralo oa ntlafatso ea boleng
Theha leano la ntlafatso ea boleng ho tsoela pele ho ntlafatsa lits'ebetso tsa tlhahiso le ho ntlafatsa boleng ba sehlahisoa ho latela lintlha tsa taolo ea boleng le liphetho tsa tlhahlobo.
9.3 Nchafatso ea theknoloji
Hlahisa mahlale a macha le lisebelisoa, ho tsoela pele ho ntlafatsa le ho ntlafatsa tlhahiso le mekhoa ea taolo ea boleng, le ho ntlafatsa ho nepahala ha tlhahlobo le katleho ea tlhahiso.
Mehato ena ea taolo ea boleng e netefatsa hore lifeme tsa meriana tsa HPMC li ka tsoela pele ho hlahisa lihlahisoa tsa boleng bo holimo, tse lumellanang le maemo nakong ea ts'ebetso ea tlhahiso, kahoo li netefatsa polokeho le katleho ea lithethefatsi.
Nako ea poso: Jul-03-2024