MAKALAH FARMASI INDUSTRI PEMBUATAN TABLET BETA LAKTAM (Amoxycillin)
DISUSUN OLEH : RINY RUMAKEY (N2!""!) KELAS A
PRO#RAM STUDI PROFESI APOTEKER UNI$ERSITAS HASANUDDIN MAKASSAR 2"!
PT% RUMAKEY FARMA
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BAB I PENDAHULUAN
Industri Industri farmasi farmasi sebagai sebagai unit usaha yang menunjang menunjang kesehatan kesehatan masyarakat mempunyai kewajiban moral dan tanggung jawab sosial untuk memp mempro rodu duks ksii
obat obat yang ang
berm bermut utu u
ting tinggi gi,,
berk berkha has siat iat
dan dan
terj terjam amin in
keamanannya. Salah satu upaya pemerintah adalah dikeluarkannya Surat Keputusan Menteri Kesehatan Republik Indonesia No. 4!Menkes!SK!II! "##$ "##$ tent tentan ang g %edo %edoma man n &ara &ara %emb %embua uata tan n 'bat 'bat yang yang (aik (aik )&%' )&%'(* (*.. %edoma %edoman n &ara &ara %embu %embuata atan n 'bat 'bat yang yang (aik, (aik, merupa merupakan kan seper seperang angkat kat aturan, petunjuk dan persyaratan yang diharapkan dalam penerapannya, menghasil menghasilkan kan produk produk yang yang terjamin.'ba terjamin.'batt merupakan merupakan kebutuhan kebutuhan utama untuk untuk menunj menunjang ang keseha kesehatan tan masyara masyarakat kat,, sehin sehingga gga perlu perlu dilaku dilakukan kan berbagai upaya untuk meningkatkan pelayanan kesehatan di bidang obat. +ntibiotik adalah at yang dihasilkan oleh suatu mikroba terutama fungi yang dapat menghambat menghambat atau dapat dapat membasmi mikroba jenis lain. (anya (anyak k antibi antibioti otik k dewasa dewasa ini dibuat dibuat se-ara se-ara semi semi sintet sintetik ik atau atau sintet sintetik ik penuh. +ntibiotika beta laktam merupakan golongan antibiotika yang pertama pertama kali ditemukan. ditemukan. Meskipun Meskipun sampai sampai sekarang sekarang banyak banyak golongan golongan antibi antibioti otika ka denga dengan n berba berbagai gai arias ariasii sifat sifat dan efakti efaktiita itasny snya a terha terhadap dap bakteri, namun demikian antibiotika ini masih sering dipergunakan sebagai
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asam asam dan basa basa serta serta dapat dapat diinak diinaktif tifkan kan oleh oleh enim enim beta beta laktam laktamas ase. e. +ntibiotika beta laktam terdiri atas dua golongan. /olongan pertama adalah penisilin beserta turunannya, yang sampai sekarang telah dapat diis diisol olas asii samp sampai ai deng dengan an gene genera rasi si keem keempa pat. t. Namu Namun n demi demiki kian an perl perlu u diperhatikan adanya sifat alergi dari pasien terhadap penggunaan penisilin dan turunannya. /olongan kedua adalah sefalosporin beserta turunannya, yang sampai sekarang telah diisolasi sampai generasi ketiga. Meskipun golong golongan an sefalo sefalosp spori orin n mempun mempunya yaii spektr spektrum um anti anti bakte bakteri ri yang yang lebar lebar,, biasan biasanya ya hanya hanya diperg diperguna unakan kan sebaga sebagaii pengo pengobat batan an alterna alternatif tif apabil apabila a peng penggu guna naan an memuaskan.
golo golong ngan an
peni penisi sili lin n
kura kurang ng
memb member erik ikan an
has hasil
yang ang
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BAB II #AMBARAN UMUM I.Industri 0armasi %1. Rumakey 0arma Industri %1 Rumakey 0arma Indonesia berada dikawasan 2l +y %atty +mbon no 4, proinsi Maluku. perusahan perusahan perusahan
yang
ini merupakan salah satu
pertama pertama kali kali didirik didirikan an di di +mbon +mbon yang se-ara se-ara resmi resmi
didi didirik rikan an pada pada tahu tahun n 3" 3" oleh oleh RIN5 RIN5 R6M+ R6M+K7 K75 5 S.Si, S.Si, +pt +pt seor seoran ang g farmasis lulusan uniersitas hasanuddin
/ambar %1. Rumakey 0arma
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3. 8ogo Industri
PT.
βRUMAKEY LAK FARMA TAM
+rti dan logo dari perusahan perusahan ini berbentuk bulat yang yang diartikan
sebagai sebagai obat yang berbentuk berbentuk tablet. tablet. %1 Rumakey 0arma memproduk memproduksi si sediaan farmasi khususnya sediaan beta la-tam, dan adapun berbentuk lingkaran lingkaran yang yang artinya global global yang dimana dapat dapat bekerja sama dengan dengan perusahan dari dari luar negeri dan dapat bersaing dengan perusahan perusahan yang lain lain yang yang memp mempro rodu duks ksii sedi sediaa aan n tabl tablet et khus khusus us tabl tablet et beta beta la-t la-tam am,, kemudian kemudian warna dari perusahan perusahan terdiri dari warna. yaitu biru, hijau dan merah, hijau merupakan tanda kesehatan yang artinya sejuk, dan ramah lingkungan , merah artinya berani dapat dapat bersaing dengan dengan perusahan lain, biru biru arti artiny nya a kete ketena naga gan n luas luas,, yang ang arti artiny nya a dapa dapatt bers bersai aing ng deng dengan an perusahan dari luar negeri . isi dan misi 9isi ". Memperhatik Memperhatikan an aspek aspek sosial, sosial, mendukung mendukung dan dan pemantapa pemantapan n upaya upaya kesehatan. 3. Mengusah Mengusahakan akan kemand kemandirian irian dibidang dibidang obat, obat, khus
a bahan bak
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Misi ".
Meningkatkan te tersedianya ob obat de dengan je jenis da dan ju jumlah yang -ukup sesuai dengan kebutuhan nyata masyarakat
3.
Meningkatkan penye nyebaraan obat se-ara merata dan terat ratur serta terjangkau oleh masyarakat.
.
Menjamin kebenaran khasiat keamanan mutu dan keabsahan obatayang beredar, serta meningkatkan kerasionalan efektiitas obat.
4.
Meman manfaatkan potensi nasion ional dibi ibidang obat men menunjang pembangunan ekonomi menuju ter-apainya kemandirian dibidang obat.
II.
STRUKTUR OR#ANISASI DALAM INDUSTRI FARMASI
Indust Industri ri farmas farmasii merupa merupakan kan indust industri ri yang yang diatur diatur se-ara se-ara ketat ketat )seper )seperti ti regist registras rasi, i, &ara &ara %embua %embuatan tan 'bat 'bat yang yang (aik, (aik, distrib distribus usi, i, perdag perdagang angan an produk yang dihasilkan, dan lain:lain* karena menyangkut jiwa manusia. %ada tahun "##$ telah ditetapkan sebuah %edoman &ara %embuatan 'bat yang (aik kemudian dilakukan pada tahun 3; dikakuan 0inalisasi &ara %embuatan %embuatan 'bat yang yang (aik dan
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+dapun perbedaan perbedaan antara &%'( dengan dengan &%'(<, yaitu = a. %ada &%'(< &%'(< perhatia perhatian n dititik beratka beratkan n pada bagian bagian persona personalia lia dan serta serta bagian bagian penand penandaan aan dan penge pengemas masan. an. Sedang Sedangkan kan dalam dalam &%'( hal ini tidak begitu diperhatikan se-ara ketat. b. %engawas %engawasan an mutu pada pada &%'( &%'( hanya hanya dipegang dipegang oleh oleh >& sedangk sedangkan an pada &%'(< selain pengawasan mutu )>&* juga terdapat bagian pemastian mutu )>+* yang mampu memberikan jaminan terhadap mutu obat yang dihasilkan. Sesuai dengan pernyataan nomor " diatas bahwa &%'(< menitik bera beratk tkan an pada pada bagi bagian an pers person onal alia ia maka maka pers person onil il yang yang beke bekerj rja a pada pada industri farmasi harus memiliki beberapa kualifikasi yang ter-antum seperti di bawah ini = a. Memilik Memilikii penget pengetahu ahuan an yg memad memadai ai b. Memiliki Memiliki keterampil keterampilan an sesuai sesuai tugasnya tugasnya -. Seha Sehatt jasma jasmani ni dan dan roha rohani ni d. Mampu membuat membuat keput keputusan usan se-ara se-ara profesi profesional onal e. Mampu Mampu beker bekerja ja sesu sesuai ai denga dengan n &%'( &%'(
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(agian Manajemen Mutu )%emastian Mutu* atau >uality +ssuran-e )>+* posisi posisi utama utama terseb tersebut ut dijaba dijabatt
oleh oleh perso personal nalia ia purna purna waktu. waktu. Kepala Kepala
(agian (agian %roduksi %roduksi dan Kepala Kepala (agian (agian Manajemen Manajemen Mutu ) %emastia %emastian n Mutu Mutu * Kepa Kepala la (a (agi gian an %e %eng ngaw awas asan an Mu Mutu tu harus harus indepe independe nden n satu satu terhadap yang lain.
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Menangani pembelian untuk bahan baku obat, bahan pengemasan,
alat laboratorium dan mesin produksi. Menentukan suplayer yang akan memasok bahan!alat yang akan
dibeli Membuat dokumentasi surat pembelian barang
3% Tc4nic'l M'n'1* / M'n'5* P*'l'-'n 6'n T0ni 7% RESEAR8H 9 DE$ELOPMENT (R 9 D) %ada %ada saat saat ini Indust Industri ri 0armas 0armasii Indon Indonesi esia a masih masih digolo digolongk ngkan an sebaga sebagaii indu indust stri ri yang yang hany hanya a mamp mampu u mela melaku kuka kan n Repr Reprod oduk uksi si obat obat 2adi 2adi dan dan sebagian (ahan (aku. ". Main +-tiitie +-tiities s ) aktiitas aktiitas pokok* pokok* R @ <= a.
•
baru baru
) original,
Licensed, copy drug/me too product * Meng Mengem emba bang ngka kan n prod produk uk yang yang suda sudah h ada ada deng dengan an perb perbai aika kan n
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Kegiatan R @ < se-ara umum meliputi = meliputi = ". Pencarian obat baru baru da dan pengembangan bentuk sediaanbaru dari
produk
yang ang
ada
)produk
yang
diperbarui*
dan
penyempurnaan formula sediaan yang sudah ada. 3. Indu Indus stri tri perlu erlu meni mening ngk katk atkan R@< R@< untuk tuk men mening ingkatk katka an pendapatan dan menjaga kelangsungan hidup perusahaan. . %erusahaa %erusahaan n yang yang baik adalah adalah yang yang selalu selalu tumbuh, tumbuh, hal hal ini dapat dapat di-apai jika laba kotor selalu meningkat. 4. %eningkata %eningkatan n laba di-apai di-apai dengan dengan antara antara lain lain melalu melaluii = - Kenaikan harga!kenaikan unit. - Kenaikan pangsa pasar dalam unit. - (ertambahnya obat baru -
-
hayati maksimal*, lebih stabil.
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a. b. -. d. e.
Meng Mengem emba bang ngka kan n %ro %rose ses s %ro %rodu duks ksi. i. Meny Menyus usun un %ro %rose sedu durr +na +nali lisi sis s dan dan %eng %engaw awas asan an.. Meny Menyus usun un Ren Ren-ana ana %en %engawas awasan an.. Menyi nyiapkan
% P*o6&c-ion M'n'1* / M'n'5* P*o6&0i Bertugas dalam produksi obat termasuk :
Memastikan bahwa obat diproduksi dan disimpan sesuai prosedur agar memenuhi persyaratan mutu yang ditetapkan.
Memberikan persetujuan kerja yang terkait dengan produksi dan memastikan bahwa petunjuk kerja diterapkan se-ara tepat.
Memeriksa Memeriksa pemelih pemeliharaan araan
bangunan bangunan fasilita fasilitas s
serta peralat peralatan an
dibagian produksi
Mema Memast stik ikan an bahw bahwa a ali alida dasi si yang yang sesu sesuai ai telah telah dila dilaks ksan anak akan an danM
tikan bahwa pelatiha
awal dan berkesinambun berkesinambun
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-
Menyakinkan bahwa produk yang dibuat konstan memiliki pensyaratan
-
kualitas yang dikehendaki. Menjaga Menjaga standar standar semua semua ospek, ospek, -ara uji dan mengaudit mengaudit kualitas, kualitas, hubungan kualitas terhadap keinginan pelanggan, dan menyampaikan kriteria kemasan kepada penjual bahan pengemas. >+ juga mempunyai fungsi dalam tahap staf dan tanggung jawab
terhad terhadap ap aspek aspek dan dan stand standar ar yang yang diingi diinginka nkan n oleh oleh >& di Indust Industri ri dan melakukan audit tentang keseragaman semua aspek dan standard yangb digunakan di semua unit. "% <&'li-y con-*ol (<8) 6ntuk menjamin kualitas kualitas produk produk yang yang dihasilka dihasilkan, n, makadilaku makadilakukan kan pengawasan terhadap mutu produk. %engawasan yang dilakukan tersebut dilakukan meliputi bahan baku, bahan kemas, proses produksi, produk antara, produk ruahan, produk jadi, produk kembalian dan sampel berkala.
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3. 1ahapan hapan produk produksi si obat obat telah telah dilaksa dilaksanak nakan an sesuai sesuai denga dengan n prose prosedur dur yang yang telah telah diteta ditetapka pkan n dan telah telah diali dialidas dasii sebel sebelumn umnya ya,, antara antara lain lain melalui ealuasi dokumentasi produksi terdahulu. . Semu Semua a peng pengaw awas asan an sela selama ma pros proses es dan dan peme pemerik riksa san n labo labora rato tori rium um terh terhad adap ap suat suatu u bets bets obat obat telah telah dila dilaks ksan anak akan an dan dan bets bets ters terseb ebut ut memenuhi spesifikasi yang telah ditetapkan sebelum didistribusikan. 4. Suat Suatu u bets bets obat obat meme memenu nuhi hi pers persy yarat aratan an mutu mutuny nya a sela selama ma waktu aktu peredaran yang telah ditetapkan. B'1i'n=>'1i'n 6'*i <8 : % B'1i B'1i'n 'n An'li n'li' ' 1ugas
dan
tanggung
jawab
bagian
analisa
antara
lain =
pemeri pemeriksa ksaan an mutu mutu bahan bahan baku, baku, pemeri pemeriksa ksaan an mutu mutu bahan bahan kemas kemas dan dan pemeriksaan produk!obat jadi.
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kadar kadar.. Selama Selama proses proses penguj pengujian ian,, bahan bahan dikara dikaranti ntina na dan diberi diberi label label BkarantinaC yang berwarna kuning. ?al:hal yang harus diperhatikan = -
%engambilan sampel bahan baku dilakukan se-ara a-ak pada bagian atas, tengah, dan bawah dari wadah. %engambilan sampel dilakukan dengan menggunakan alat t$ief sampler .
-
%engambil %engambilan an sampel dilakukan dilakukan se-ara se-ara a-ak untuk setiap batc$ batc$ dengan
n
rumus
D". 6ntuk bahan yang identitasnya kurang jelas, wadah kotor,
pabrik pabrik pembuat pembuat berbeda dari biasanya, biasanya, atau bahan berasal berasal dari supplier yang baru maka sampling dilakukan dilakukan terhadap semua wadah dalam batc$. batc$. -
%engambilan -ontoh harus dilakukan dalam ruang sampling dengan tepat untuk men-egah terjadinya kontaminasi. ?al:hal yang perlu diperhatikan adalah sebagai berikut =
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Selain Selain itu bagian bagian analis analisa a mengel mengeluar uarka kan n lembar lembar B6i, 6i,o oi iii <8C <8C yang menerang menerangkan kan status status
bahan bahan baku.
diman dimana a tembus tembusann annya ya disera diserahka hkan n ke bagian bagian %%I& %%I& untuk untuk peren peren-an -anaan aan produksi dan bagian keuangan untuk pembayaran. b.
%emeriksaan mutu bahan kemas %emeriksaan dilakukan untuk menjamin bahwa bahan kemas yang digunakan benar:benar sesuai spesifikasi yang ditentukan. 1ujuan yang ingin di-apai adalah bahan pengemas tersebut dapat melindungi sediaan obat. %engu %engujia jian n terhad terhadap ap bahan bahan kemas kemas melipu meliputi ti label, label, brosur brosur,, wadah wadah karton karton,, alumin aluminium ium foil, foil, botol botol dan dan tutup tutup botol. botol. %engaw %engawasa asan n dilaku dilakukan kan terhadap penampilan fisik wadah, kesesuaian bahan dan hasil -etakan dengan spesifikasi yang telah ditentukan )warna, penandaan, desain dan
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disolusi. 2% Pn1' Pn1'?' ?''n 'n 6'l' 6'l'm m P*o P*o ( In Process Control ) ) %engawas %engawasan an dalam dalam proses proses )I%&* merupakan merupakan pengawasa pengawasan n yang yang dila ilaksan ksanak akan an
selam elama a
prose roses s
bert bertan angg ggun ungj gjaw awab ab untu untuk k terja terjadi diny nya a
kesa kesala laha han n
pers persy yarat aratan an yang ang
pro produk duksi
mela melaku kuka kan n
berla erlan ngsu gsung. ng.
peng pengaw awas asan an untu untuk k
Seks Seksii
I%& I%&
menmen-eg egah ah
sehi sehing ngga ga prod produk uk yang yang diha dihasi silk lkan an meme memenu nuhi hi
tela telah h
dite ditent ntuk ukan an..
I%& I%&
beru berupa pay ya
apab apabil ila a
terj terjad adii
kesalahan yang selama berlangsungnya proses produksi dapat segera
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pembuatan tablet yang efektif terutama pada dosis efektif terlalu tinggi untuk pen-etakan pen-etakan langsung, langsung, dan obatnya obatnya peka terhadap terhadap pemanasan pemanasan,, kelembaban atau keduanya. Metode ini banyak digunakan untuk membuat tabl tablet et aspi aspiri rin n atau atau ita itami min n dan dan tabl tablet et anti antibi biot otik ik.. .. %ada %ada pros proses es ini, ini, komponen:komponen tablet dikompakkan dengan mesin -etak tablet atau mesin khusus )roller -ompa-tor*. Setelah serbuk di-ampur, -ampuran serbuk ditekan ke dalam die, yang besar dan dikompakk dikompakkan an dengan dengan punhpunh- permukaan permukaan datar. Massa
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Kerugian metode /ranulasi kering =
•
Memerlukan mesin $ea(y duty )harganya )harganya mahal*
•
Far warna sukar homogen )tidak terdispersi merata*
•
&enderung menghasilkan partikel:partikel halus )fines ) fines** yang lebih banyak dibanding dengan metode granulasi basah, sehingga tablet sering raouh atau kurang kuat dan resiko kontaminasi lebih tinggi
• +lat.mesin C$ilsonator tidak bisa digunakan untuk obat yang tidak larut karena karena adanya adanya kemungki kemungkinan nan hambatan hambatan ke-epatan ke-epatan disolusi disolusi
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maupun
kerusakan
7rror rror==
Refer eferen en-e
sour sour-e -e
not not
foun found dkemasan,
reko rekome mend ndas asii dari dari (ala (alaii %'M %'M kare karena na fakt faktor or mutu mutu dan dan timb timbiln ilnya ya efek efek sampin samping g yang yang merug merugika ikan n atau atau membah membahay ayaka akan n konsu konsumen men..
menyampaikan
pembe mberitahuan
yang ang
berkaitan
dengan
pengem pengembal balian ian produk produk terseb tersebut ut disert disertai ai dengan dengan dokume dokumen n yang yang berisi berisi jumlah produk, jenis produk, no.bat-h, tempat asal pengembalian dan alasan pengembalian produk. %ena %enang ngan anan an prod produk uk kemb kembal alia ian n oleh oleh guda gudang ng obat obat jadi jadi adal adalah ah
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-
Mengalami kerusakan baik isi maupun kemasannya
-
%roduk yang dikembalikan dalam jumlah ke-il
-
%roduk kembalian karena kadaluarsa 6ntuk produk yang dimusnahkan karena alasan kadaluarsa atau
rusa rusak, k, dibu dibuat atka kan n #estruction #estruction *euisitio *euisition n yang yang ditand ditandat atan anga gani ni &uality #epartment , PP)C #epartment , -inance #epartment , Plant #irector serta 'eneral !anager jika jika nilai produk yang dimusnahkan tersebut lebih dari 3 juta. Selanjutnya produk dikelompokkan berdasarkan karakteristiknya dan
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3. %embu %embuata atan n susp suspens ensii bakte bakteri ri (akt (akter erii diin diinok okul ulas asik ikan an ke medi media a agar agar mirin miring, g, kemu kemudi dian an diinkubasi selama 34 pada suhu A G H &. (iakan yang telah tumbuh dibilas dengan Na&l ,# J )fisiologis*, suspensi kemudian
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diin diinku kuba basi si pada pada suhu suhu A G H & sela selama ma 34 jam. jam. Sela Selanj njut utny nya a diba-a ona hambat dengan jangka sorong dalam satuan mm. !% Pm'nPm'n-'&' '&'n n P'*-i P'*-i0l 0l Mi0*o> Mi0*o>' ' %emantaua %emantauan n partikel partikel mikroba mikroba dilakukan dilakukan dibawah dibawah Laminar Air -lo
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-ungsi Pokok PP)C: ". 0ungsi 0ungsi %eren-an %eren-anaan aan Mene Menent ntuk ukan an sasaran.
sasa sasara ran n
dan dan
lang langka kah: h:la lang ngka kah h
untu untuk k
menmen-ap apai ai
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4. Meng Menghi hitu tung ng stan standa darr tena tenaga ga kerj kerja a seti setiap ap tahu tahun n berd berdas asar arka kan n data data lapangan. A. Menghitung Menghitung standa standarr yield berdasark berdasarkan an realisasi realisasi produksi produksi setiap setiap tahun. tahun. ;. Sebagai Sebagai juru bi-ara bi-ara perusa perusahaan haan dalam dalam hal hal kerja kerja sama denga dengan n perusahaan.
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%%I& %%I&!% !%ro rodu du-t -tio ion n
%lan %lanni ning ng
@
In Inento entory ry
&ont &ontro roll,
melakukan
peren-anaan atas bahan awal yang dibutuhkan untuk proses produksi melalui sistem yang disebut = Material ReEuirement %lanning !MR%. !MR%. %ur-hasing %ur-hasing!%emb !%embelian elian melaksana melaksanakan kan pemesana pemesanan n pada suplier suplier
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•
Memperbaik Memperbaikii homogeni homogenitas, tas, karena karena tidak terjadi terjadi peristiwa peristiwa migrasi migrasi obat atau bahan pewarna
Kerugian metode /ranulasi kering =
•
Memerlukan mesin $ea(y duty )harganya )harganya mahal*
•
Far warna sukar homogen )tidak terdispersi merata*
•
&enderung menghasilkan partikel:partikel halus )fines ) fines** yang lebih banyak dibanding dengan metode granulasi basah, sehingga tablet sering raouh atau kurang kuat dan resiko kontaminasi lebih tinggi
• +lat.mesin C$ilsonator tidak bisa digunakan untuk obat yang tidak larut karena karena adanya adanya kemungki kemungkinan nan hambatan hambatan ke-epatan ke-epatan disolusi disolusi )adanya tekanan merubah sifat obat* Masalah yang sering dihadapi dalam metode &etak langsung antara lain adalah = ". Masala Masalah h teknis teknis,, yaitu yaitu sulitny sulitnya a menemu menemuka kan n bahan bahan dengan dengan sifat alir dan kompressibilitas yang baik 3. Masa Masala lah h ekon ekonom omis is,, dima dimana na baha bahan: n:ba baha han n deng dengan an sifa sifatt alir alir dan dan kompre kompresib sibili ilitas tas yang yang baik baik terseb tersebut ut biasan biasanya ya harga harganya nya mahal, mahal, bahkan bisa beberapa kali lipat (ahan pengemas
Menurut ?' Semua jenis bahan, termasuk bahan hasil -etakan, yang digunakan
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Menurut &%'( Semua bahan yang dipakai dalam proses pengemasan produk ruahan untuk menghasilkan produk jadi.
Menurut Mil G S1< G 3H G I+ )+S* %roses dan prosedur yang dilakukan untuk men-engah penguraian dan kerusakan bahan dalam hal ini termasuk pembersihan, pengeringan, pengawetan, pembungkusan, penandaan dan penggunaan.
Syarat:syarat bahan pengemas -
?arus melindungi preparat dari keadaan lingkungannya lingkungannya
-
1idak boleh bereaksi dengan produk
-
1idak boleh memberikan rasa dan bau kepada produk
-
1idak toksik
-
-
?arus tahan banting
K1i'-'n Pn1m''n (Packaging (Packaging ) (agian
pengemasan
baik
primer
maupun
sekunder
bertan bertanggu ggungj ngjawa awab b kepad kepada a Manage Managerr %roduk %roduksi. si. (agian (agian pengem pengemasa asan n bertugas untuk mengemas produk:produk ruahan yang telah dinyatakan lulus oleh bagian>&. 1ujuan dari pengemasan produk adalah =
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e* Memb Member erii info inform rmas asii tent tentan ang g prod produk uk melip meliput utii nama nama prod produk uk,, isi, isi, nomo nomorr batbat-h, h, nama nama pabr pabrik ik yang yang memp mempro rodu duks ksii dan dan tang tangga gall kadaluarsa f* Memb Member erii nila nilaii tamb tambah ah pada pada prod produk uk yaitu yaitu = pena penamp mpil ilan an,, bent bentuk uk lebih menarik, men-egah pemalsuan )identitas*. (agian pengemasan dibagi menjadi 3 unit yaitu= 3. %eng %engem emas asan an %rim %rimer er %engem %engemasa asan n primer primer dilaku dilakukan kan di ruang ruang produk produksi si ) grey grey area area* yang meli melipu puti ti stripping , pengem pengemasa asan n dalam dalam plasti plastik k )$ospital $ospital pack * sert serta a filling sediaan sediaan liEuida. 6ntuk menjamin mutu hasil pengemasan pengemasan maka maka sela selalu lu dila dilaku kuka kan n
I%&. I%&. I%& I%&
untu untuk k peng pengem emas asan an prim primer er meli melipu puti ti
pemeriksaan isi setiap kemasan )olume -ontrol*, dan uji kebo-oran strip atau botol. %ada uji kebo-oran strip digunakan 4 strip sebagai sampel sampel uji, uji, batas batas maksim maksimal al kebo-o kebo-oran ran yang yang diperb diperbole olehk hkan an adalah adalah tergantung dari sifat produk yang distrip. 6ntuk kapsul dan itamin tidak boleh terjadi kebo-oran karena sediaan tidak tahan kelembaban. Sedangkan untuk tablet lainnya batas maksimal kebo-oran adalah biji.
. %eng %engem emas asan an Sek Sekun unde der r %engem %engemasa asan n sekund sekunder er dan tersie tersierr dilaku dilakukan kan dalam dalam ruanga ruangan n black
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-
Coding = pembe pemberia rian n nomor nomor bat-h dan epired date date pada etiket dandos
-
%emberian brosur!insert
-
Memasukkan hasil pengemasan kedalam bo dan master bo.
Setelah tahap pengemasan sekunder maka dilakukan final inspection oleh bagian >& meliputi = e. %eny %enyia iapa pan n labe labell Kebenaran Kebenaran label, hasil hasil -etakan! -etakan! printing printing No.(at-h, Manufa-turing date dan 7p.date f. %elip elipa atan tan inse insert rt Kebenaran insert, insert -a-at!rusak, kerapian lipatan g. %rinti %rinting ng dus dan master master bo Kebenaran dus dan master bo, kebenaran penandaan No. bat-h, 7p.date, dan Manufa-turing date h. %eng engepak pakan Kebe Kebena nara ran n isi, isi, kebe kebena nara ran n dus dus dan dan mast master er bo, bo, kebe kebena nara ran n penandaan, kebenaran insert. Sebelu Sebelum m proses proses pengem pengemas asan an dimula dimulaii terleb terlebih ih dahul dahulu u diperi diperiksa ksa kesiapan ruang untuk memastikan bahwa perlengkapan dan ruang kerja dalam keadaan bersih dan sisa produk lain tidak ada. ?al ini bertujuan untuk menghinda menghindari ri terjadinya terjadinya kesalahan! kesalahan!tertuk tertukarny arnya a produk produk yang akan kemas. %ada tiap jalur pengemasan, terdapat papan yang menunjukkan
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pengem pengemasa asan n selesa selesaii juga juga dilaku dilakukan kan penimb penimbang angan an master master bo sesuai sesuai deng dengan an bobo bobott yang yang dite ditent ntuk ukan an.. Mast Master er bo bo yang yang suda sudah h diti ditimb mban ang g ditempatkan diruang karantina, setelah mendapat persetujuan dari bagian >& maka master bo segera dipindahkan ke gudang obat jadi. 2umlah prod roduk
yang ang
dip diperol erole eh
dan
sis sisa
kemas emasan an
yang ang
tida tidak k
terp terpa akai kai
didokumentasikan dalam laporan harian kemas sekunder. P*o ,m>&'-'n -'>lSe-ara umum, tablet dapat dibuat dengan -ara atau metode, yaitu =
•
Metode /ranulasi (asah )et )et granulation* granulation*
•
Metode /ranulasi Kering )dry )dry granulation* granulation* , dan
•
Metode Kempa langsung )direct ) direct compression* compression*
+86R %R'S7S %7M(6+1 %7M(6+1+N +N 1+(871 1+(871 (71+ 8+K1+M 8+K1+M M71'<7 /R+N68+SI K7RIN/
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Pencampuran awal
Granulasi
Cek ipc !"# $!oss on /#rying%
Slugging $roller compacting%
Pengayakan kering
Pencampuran akhir
Cek &PC Penampilan Kebocoran Penan'aan
Pencetakan tablet
Cek &PC Keseragaman ka'ar
Pengemasan Primer
Cek &PC Keseragaman Keseragaman ka'ar Keseragamna Keseragamna bobot Kekerasan Kerapuhan (aktu hancur 'isolusi
Pengemasan sekun'er
Cek &PC
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%emeriksaan ini dilakukan untuk memeriksa susut granul dengan menggunakan alat !oisture
Analy8er .
pengeringan Sampel
yang
diambil untuk pemeriksaan Z A g. b. Sifat alir granul 6ji 6ji alir alir gran granul ul dila dilaku kuka kan n deng dengan an alat alat granul granules es flode flode tester tester . 2umlah 2umlah sampe sampell yang yang diguna digunakan kan adala adalah h 3 g. %arame %arameter ter yang yang diukur diukur adalah ke-epatan alir granul dan sudut istirahat. 6ji ke-epatan alir granul dilakukan sebagai berikut = Sampel granul dimasukkan ke dalam -orong dengan -ara dialirkan lewat dinding dinding -orong -orong dimana dimana lubang lubang bagian bagian bawah bawah -orong -orong tertutup. tertutup. Setelah Setelah semu semua a samp sampel el gran granul ul masu masuk, k, luba lubang ng bawa bawah h dibu dibuka ka samb sambil il diuk diukur ur ke-epa ke-epatan tan alirny alirnya a menggu menggunak nakan an stopwa stopwat-h t-h.. Meja Meja uji diaala diaalasi si dengan dengan kert kertas as untu untuk k mena menamp mpun ung g gran granul ul yang ang kelu keluar ar dari dari -oro -orong ng.. ?as ?asil tamp tampun unga gan n yang yang berb berben entu tuk k keru keru-u -utt diuk diukur ur diam diamet eter er dan dan ting tinggi giny nya, a, kemudaian di-ari sudut istirahatnya )[*. -. Bulk -. Bulk #ensity 6ji ini dilaku dilakukan kan dengan dengan mengg mengguna unakan kan alat +ap +ap #ensity +ester. +ester.
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6ji ini dilaku dilakukan kan dengan dengan mengg mengguna unakan kan alat +ap +ap #ensity +ester. +ester. (obot (obot sampel sampel yang yang digunakan digunakan 3 g. %emeriksa %emeriksaan an
dilakukan dilakukan
dengan dengan
-ara memasukkan granul sampai " ml ke dalam gelas ukur kemudian alat dijalankan dan diamati olume pada tiapa interal " ketukan dari " sampai A ketukan, kemudian " ketukan.%ada " ketukan amati olume granul pada tiap interal " ketukan sampai total 4 ketuka ketukan. n. ?itung ?itung tap densit density y pada pada saat saat olum olume e konsta konstan n selama selama kali kali berturut:turut. e.
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pen-etak tablet diran-ang dengan komponen:komponen dasar sebagai berikut = ". ?opp ?opper er untu untuk k meny menyim impa pan n dan dan mema memasu suka kan n gran granul ulat at yang akan akan dikempa 3. l- mli,&-i : ". Kese Kesera raga gama man n bobo bobott 6ji ini menggunakan timbangan. Sampel diambil dari $opper kanan kanan dan $opper kiri pada awal, tengah dan akhir produksi. %emeriksaan ini juga dilakukan oleh bagian produksi setiap menit. 3. Kerapuhan 6ji ini menggunakan alat -riablilty tester . Sampel yang digunakan diambil
dari $opper kanan maupun kiri pada awal, tengah dan akhir
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+lat yang digunakan digunakan #ial +$ickness tester . ;. Kesera Keseragam gaman an kada kadarr bahan bahan aktif aktif & menggunakan metoda anlisa yang dikeluarkan R@< H. 6ji 6ji dis diso olusi lusi +lat yang digunakan adalah disolution %enetapa apan n kadar kadar disolution tester tester . %enet dilakukan dengan menggunakan metoda analisa yang dikeluarkan oleh R@< P*m''l'4'n D'l'm Pnc-'0'n T'>lMasalah:masalah yang dapat mun-ul selama proses pen-etakan tablet se-ara umum, seperti =
•
Capping = pemisahan sebagian atau keseluruhan bagian atas!bawah
• • •
tablet dari badan tablet 8aminasi = pemisahan tablet menjadi dua bagian atau lebih C$ipping = = keadaan dimana bagian bawah tablet terpotong Cracking = = keadaan dimana tablet pe-ah, lebih sering di bagian atas:
•
tengah Picking = perpid perpidaha ahan n bahan bahan dari dari permuk permukaan aan tablet tablet dan menemp menempel el pada permukaan punc$ permukaan punc$ "ticking = keadaan dimana dimana granul menempel menempel pada dinding die )ada
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• • •
Melekat pada die dan die dan sulit untuk dikeluarkan (unyi keras pada mesin 1ablet kopak, jelek, sisi tablet kasar, kadang:kadang hitam
%enyebab =
• +ntiadheren kurang • 8ubrikan kurang atau tidak tepat &ontoh = 1ablet asetosal dengan Mg stearat lengket, seharusnya diguna digunaka kan n asam asam steara stearatt )yang )yang mikroni8e karena karena fungsi fungsi lubrikan lubrikan adalah antar partikel sehingga kalau halus akan terselimuti oleh
•
lubrikan*. Kand Kandun unga gan n air air )asp )aspek ek kada kadarr air* air* ting tinggi gi akan akan meny menyeb ebab abka kan n penempelan pada
•
die, die, seda sedang ngka kan n
kada adar
air ren rendah dah dap dapat
menyebabkan laminating atau capping . Kemungkinan karena interaksi kimia atau fisika, -ontoh interaksi fisika fisika etoksi etoksi benamin benamin dengan dengan kafein, kafein, gliseril gliseril guaiakola guaiakolatt dengan dengan
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dilaku dilakukan kan dengan dengan menamb menambahk ahkan an pembas pembasah ah ke dalam dalam laruta larutan n pengikat, yaitu bahan pembantu yang tidak menguap tapi basah,
•
-ontoh %ropilen glikol atau gliserin. 2ika terjadi terjadi lengket mungkin mungkin karena punc$ punc$ da dan die yang rusak, seba sebab b kala kalau u -a-a -a-att pada pada punc$, punc$, maka maka akan akan meleka melekatt sehing sehingga ga
•
ratakan punc$ ratakan punc$ dan dan die. die. Kalau Kalau mungki mungkin n pen-e pen-etak takan an pada pada suhu suhu rendah rendah dan humud humudita itas s rendah karena khusus untuk bahan aktif dengan titik leleh rendah atau atau terj terjad adii -amp -ampur uran an eute eutekt ktik ik maka maka at at -amp -ampur uran an eute eutekt ktik ik semak semakin in mudah mudah menye menyerap rap air. air. &ontoh &ontoh = Kombin Kombinasi asi ampisi ampisilin lin dengan asam klaulanat, dimana asam klaulanat mudah han-ur dengan kelembaban dan temperatur yang tinggi. 'leh karena itu,
•
pembuatannya pembuatannya dilakukan dalam suhu dan R? yang rendah. %erubahan bahan pengisi, bahan pengisi dengan titik leleh tinggi
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• 6bah ukuran granul • 1ambah adsorben • %erbaiki alat • +lat dipoles, sehingga adhesiitas tablet dan pun-h pun-h sangat ke-il. .% Capping /Laminating /Laminating %enyebab =
• •
1erjebaknya udara pada tablet karena granul sangat halus %orositas tinggi, khususnya pada penggunaan pun-h yang baru,
• •
yaitu dengan adanya udara yang terjebak antara pun-h dan die Kekerasan yang terlalu rendah atau terlalu tinggi )ada yang optimal* /ran /ranul ul yang terl terlal alu u kerin kering, g, -ara -ara = tamb tambah ahka kan n dala dalam m pela pelaru rutt
• •
pengikat tambahkan bahan -air dan tidak mudah menguap Fat pengikat yang kurang tepat. %engi %engikat kat yang yang jumlah jumlahny nya a terlalu terlalu sediki sedikitt )tepat )tepat tetapi tetapi jumlah jumlahny nya a
• •
ke-il* %enanggulangannya %embuatan granul diulang jika penyebabnya adalah kelebihan atau
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• • • •
%un-h dan die supaya die supaya di poles 6ntuk ukuran granul yang besar, kurangi partikel granul.
% K*'1'm'n >o>oPny>'> ,*-'m' :
• +liran kurang baik •
•
pen-etakan. Sistem Sistem pen-a pen-ampu mpuran ran yang yang tidak tidak benar benar,, sehin sehingga gga mesin mesin harus harus terkun-i baik terutama pun-h bawah karena dapat berubah:ubah sehingga bobot berbeda:beda.
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• •
Kurangi kadar air %embuatan %embuatan granul granul baru sehingga sehingga menyebab menyebabkan kan porositas porositas ke-il, ke-il, distribusi granul optimal sehingga aliran bagus.
3
K*'1'm'n K'n6&n1'n
• •
Kadar bahan aktif dibawah A mg (ila perbandingan kadar bahan aktif dengan bobot tablet lebih ke-il dari pada AJ
%enyebab jeleknya keseragaman kandungan =
• •
Karena aliran jelek %en%en-am ampu pura ran n preg pregra ranu nula lasi si tida tidak k bena benarr maka maka tent tentuk ukan an dulu dulu
•
homogenitas at aktif dalam granul )di pabrik* Karena Karena kada kadarr fines fines tinggi maka porositas tinggi )bobot berbeda:
•
beda* Kandungan air yang tinggi sehingga aliran kurang baik
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1%. +nsel ?&. "#$A. Pengan Pengantar tar Bentu Bentuk k "ediaa "ediaan n -arma -armasi si . 7dis 7disii I9. I9. 1erjema rjemaha han n oleh oleh Ibra Ibrahi him m 0, +sman smani iar ar,, dan dan +isya isyah h I. "#$# "#$#.. 6niersitas Indonesia %ress. 2akarta. 1=. 8ieb 8ieber erma man, n, ?erb ?erber ertt +, 8a-h 8a-hma man n 8, 2ose 2oseph ph (. S-hw S-hwar art t.. "#$# "#$#.. %harma %harma-eu -eutiti-al al