CPOB SEDIAAN

STERIL
SI Farmasi B2/2016
 Kelompok 1
Dwi izzatul Lailiyah
1
16020200027

Eka Ferdianti Lutvinda

2
160

Ofraliya Renna Eka Sugiyanto

3
16020200064

Pahri
4 160
 Definisi Produk Steril
Sediaan steril adalah sedian yang selain memenuhi persyaratan
fisika-kimia juga  persyaratan steril. Steril berarti bebas mikroba.
Sterilisasi adalah proses untuk mendapatkan kondisi steril. 
Sediaan steril secara umum adalah sediaan farmasi yang
mempunyai kekhususan sterilitas dan bebas dari
mikroorganisme
Tujuan CPOB
CPOB adalah suatu pedoman yang menyangkut seluruh aspek produksi
dan pengendalian mutu, bertujuan untuk menjamin bahwa produk obat
dibuat senantiasa memenuhi persyaratan mutu yang telah ditentukan se
suai dengan tujuan penggunaannya.
Keuntungan dan kerugian steril
Keuntungan :
1.aksi obat lebih cepat
2.cocok untuk obat inaktif jika diberikan oral
3.obat yang mengiritasi bila diberikan secara oral
4. kondisi pasien (pingsan, dehidrasi) sehingga tidak memungkinkan
obat diberikan secara oral.
Kerugian : 
1.tidak praktis
2.butuh alat khusus (untuk injeksi)
3.sakit
4.risiko, kalau alergi atau salah obat maka tidak bisa langsung dihilangkan
5.butuh personil khusus, misal di rumah sakit oleh dokter atau perawat.
Cara Pembuatan Obat yang Baik (CPOB) untuk
Sediaan Steril
Prinsip dari CPOB adalah memperkecil pencemaran mikroba, partikula
t, dan  pirogen. Hal-hal yang perlu diperhatikan:
 Keberadaan ruang penyangga untuk personil
dan /atau peralatan dan bahan Pembuatan produk
dan proses pengisian dilakukan pada ruangan
terpisah
 Kondisi “operasional dan non operasional”
hendaklah ditetapkan untuk
 tiap ruang bersih.
Empat kelas kebersihan pada pembuatan produk steril:

Kelas Kelas Kelas Kelas

A B C D
Untuk kegiatan yang Untuk pembuatan dan Untuk melakukan tahap
Untuk melakukan tahap
berisiko tinggi, misalnya
pengisian secara aseptik, pembuatan produk steril pembuatan produk steril
pengisian wadah tutup dengan tingkat risiko lebih
kelas ini adalah lingkungan dengan tingkat risiko lebih
karet, ampul, dan vial latar belakang untuk zona rendah. Contoh kegiatan:
rendah.Contoh kegiatan:
terbuka, penyambungan
kelas A. Pembuatan larutan penanganan komponen
secara aseptik. Umumnya setelah  pencucian.
kondisi ini dicapai dengan
memasang unit aliran udara
laminar (laminar air flow)
dengan kecpatan 0,36-0,54
m/detik. Contoh kegiatan:
pembuatan dan pengisian
aseptik
 Gambaran umum pembuatan sediaan
steril ada 2 macam, yaitu :

Pada pembuatannya, setiap proses dari awal

Aseptic persiapan hingga sudah dikemas selalu
processing dilakukan secara aseptik, sehingga hasil yang
diperoleh steril

Terminal pada pembuatannya tidak terlalu aseptik

seperti aseptic  processing, tapi di akhir
sterilization
proses, dilakukan sterilisasi secara
menyeluruh
Cara Penggunaan Sediaan Steril
1. Sediaan steril untuk mata
1. Cuci tangan dengan air dan sabun
2. Kocok obat hingga tercampur merata (untuk tetes mata)
3. Tengadahkan kepala, tarik kebawah kelopak mata bawah sampai membentuk cekungan 4.
Tempatkan botol tetes mata atau salep dekat dengan matam jangan sampai menyebtuh mata,
wajah atau permukaan lain
4.  Arahkan mata melihat keatas
5. Teteskan tetes mata sesuai dengan aturan pakai (untuk tetes mata)
6. Oleskan salep mata di dalam cekungan mata sepanjang 1 cm atau sepanjang cekungan mata
7. Pejamkan mata selama 1-2 menit, jangan mengkedip-kedipkan mata
8. Bersihkan kelebihan tetes atau salep yang tercecer mengenai wajah
9. Beri jarak pemakaian lebih dari satu macam tetes mata atau salep mata
10. Berikan jarak minimal 5 menit dengan mendahulukan pemakaian tetes mata
11.  baru pakailah salep mata dan beri jarak 10 menit
12. Bila memakai lensa kontak, lepas dan pasang kembali sekitar 15 menit setelah  pemakaian
tetes mata atau salep mata.
13. Tutup kembali tetes dan salep mata anda, jangan mencuci ujungnya
2. Sediaan steril 3. Sediaan Steril Tetes Telinga
parenteral 1. Cuci tanganBerdiri atau duduk depan cermin 2.
2.  Buka tutup botolPeriksa ujung penetes dan pastikan tidak
Dimasukkan ke dalam pecah atau patah 3.
tubuh dengan 3.  Jangan menyentuh ujung penetes dengan apapun
menggunakan alat usahakan tetap bersih 4.
suntik. 4.  Posisikan kepala miring dan pegang daun telinga agar
memudahkan memasukkan sediaantetes telinga. 5.
5.  Pegang obat tetes telinga dengan ujung penetes di
bawah sedekat mungkin dengan lubang telinga tetapi
tidak menyentuhnya  
6. Perlahan-lahan tekan botol tetes telinga sehingga jumlah
tetesan yang diinginkan dapat menetes dengan benar
pada lubang telinga. 7. 
Thank you
7. Diamkan selama 2-3 menit 8.
8. Bersihkan
Insert the titlekelebihan cairan
of your subtitle Here dengan tisuTutup kembali
obat tetes telinga,  jangan mengusap atau mencuci ujung
penutupnya.
 Evaluasi sediaan steril
1.Uji pH
Cek pH larutan dengan menggunakan pH
meter atau kertas indikator universal.
Dengan pH meter : Sebelum digunakan,
periksa elektroda dan jembatan garam.
Kalibrasi pH meter. Pembakuan pH meter
: Bilas elektroda dan sel beberapa kali
dengan larutan uji dan isi sel dengan
sedikit larutan uji. Baca harga pH.
Gunakan air  bebas CO2 untuk pelarutan
dengan pengenceran larutan uji.
2. Uji kejernihan
Pemeriksaan dilakukan secara visual
biasanya dilakukan oleh seseorang yang
memeriksa wadah bersih dari luar di bawah
penerangan cahaya yang baik, terhalang
terhadap refleksi ke dalam matanya, dan
berlatar belakang hitam dan putih, dengan
rangkaian isi dijalankan dengan suatu aksi
memutar, harus benar-benar bebas dari
 partikel kecil yang dapat dilihat dengan
mata.
Lanjutan…
3. Uji kebocoran 4. Uji sterilitas
Letakkan ampul di dalam zat Asas : larutan uji + media perbenihan,
warna ( biru metilen 0,5 – 1% ) inkubasi pada 20˚c – 25˚c. Kekeruhan /
dalam ruangan vakum. Tekanan  pertumbuhan mikroorganisme ( tidak steril )
atmosfer berikutnya kemudian
menyebabkan zat warna
berpenetrasi ke dalam lubang,
dapt dilihat setelah bagian luar
ampul dicuci untuk membersihkan
zat warnanya.
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