The Pharmacist Room: 2021

Tujuan Protokol Validasi Pembersihan Mesin dan metode yang digunakan

 Tersedianya prosedur pembersihan yang efektif untuk membersihkan peralatan pengolahan hingga pengemasan primer adalah penting untuk mencegah risiko kontaminasi silang terhadap produk berikutnya yang diproduksi di peralatan yang sama.

 

Kontaminasi dapat bersumber dari:

  • bahan aktif obat dari produk sebelumnya
  • bahan pembersih / deterjen
  • mikroba dari lingkungan
  • bahan lain (debu, pelumas)

 

Pembersihan dilakukan setelah pembuatan ataupun pengemasan suatu produk. Hasil pembersihan efektif akan menghilangkan sisa cemaran bahan aktif obat sisa deterjen maupun tingkat cemaran mikroba bila mengikuti prosedur yang telah divalidasi. Setelah zat penanda (marker) ditetapkan sesuai tingkat kelarutan maupun toksisitasnya, maka prosedur penetapan kadar residu disiapkan dan divalidasi.

 

Pengamatan dan pengujian dilakukan terhadap:

  • Pengamatan secara visual kebersihan permukaan alat yang kontak langsung dengan produk
  • Kualitas air bilasan akhir
  • Residu yang diambil secara usap dan / atau bilas
  • Cemaran mikroba pada permukaan alat yang kontak dengan produk.

 

Metode Pengambilan Sampel (Cuplikan)

 

  1. Metode Apus (swab sampling method)
  • Prinsip: Residu diperoleh dengan mengapus (swab) langsung pada permukaan alat/ruangan yang kontak dengan produk. Hasil swab dianalisis untuk kandungan residu setelah melalui proses ekstraksi atau untuk kandungan mikro-organisme setelah melalui kultur mikroba dan inkubasi.
  • Merupakan metode pengambilan sampel dengan cara menggunakan bahan apus (swab material) yang dibasahi dengan pelarut yang langsung dapat menyerap residu dari permukaan alat.
  • Bahan yang digunakan untuk sampling harus kompatibel dengan solvent dan metode analisanya.
  • Tidak ada sisa-sisa serat yang mengganggu analisa.
  • Ukuran material harus disesuaikan dengan area sampling

     Sedangkan bahan pelarut (solvent), harus :

  • Disesuaikan dengan spesifikasi bahan yang diperiksa.
  • Tidak mempengaruhi stabilitas bahan yang diuji.
  • Sebelum dilakukan validasi, harus dilakukan pemeriksaan/ uji perolehan kembali (recovery test) dengan larutan yang diketahui kadarnya.

Metode pengambilan sampel dan pengujian:

  • Bersihkan kapas usap dengan merendam dalam methanol / pelarut sesuai validasi metode selama 5 menit, sonifikasi dan peras.
  • Pada saat pengambilan sampel, basahkan kapas usap dalam metanol/pelarut sesuai validasi, peras kelebihan pelarut dengan menekan di bibir bagian dalam wadah.
  • Sampel diambil di area kritis sesuai protokol.
  • Letakkan bingkai SS 5 x 5 cm di area yang akan diusap.
  • Usap luas area yang ditentukan sesuai arah yang benar.
  •  Masukkan kembali kapas usap ke dalam tabung bersih, tutup.
  • Sampel di uji dengan metode analisis yang telah divalidasi.

 

  1. Metode Pembilasan Terakhir (Rinse sampling method)
  • Prinsip: Residu diperoleh dengan mengumpulkan pelarut pembilas yang telah kontak dengan permukaan alat dimana produk diproses. Hasil bilas kemudian dianalisis untuk kandungan residu dan atau kandungan mikroba.
  • Umumnya dilakukan untuk alat/mesin yang sulit dijangkau dengan cara apus (banyak pipa, lekukan, dan lain-lain).
  • Pelarut pembilas harus tidak boleh menyebabkan penguraian/degradasi residu.
  • Pelarut pembilas harus kontak dengan permukaan alat dalam waktu yang cukup agar residu dapat larut sempurna.

Metode pengambilan sampel dan pengujian:

  •  Kumpulkan 500 ml air bilasan terakhir dan 500 ml secara aseptis untuk uji cemaran mikroba.
  • Ambil juga sampel Air Murni yang digunakan untuk membilas sebagai pembanding.
  • Air bilasan diuji terhadap parameter pH, konduktivitas, logam berat, nitrat, TOC, cemaran mikroba dan dibandingkan dengan kualitas air murni yang digunakan dalam pembilasan.

 

  1. Metode dengan menggunakan placebo
  • Prinsip: Residu diperoleh dari batch produk plasebo yang dibuat dengan cara simulasi dala kondisi yang sebenarnya. Contoh produk sepanjang proses produksi melalui suatu rangkaian alat kemudian dianalisis untuk kandungan residu atau kandungan mikro-organisme.
  • Pengambilan sampel yang dilakukan dengan cara pengolahan produk yang bersangkutan tanpa bahan aktif dengan peralatan yang sudah dibersihkan kemudian dianalisa.

Kriteria penerimaan dalam validasi pembersihan adalah sebagai berikut :

1.        Secara visual

Secara visual alat yang dibersihkan tidak terdapat sisa serbuk produk sebelumnya dan busa dari bahan pembersihan yang digunakan.

2.        Air bilasan akhir memiliki pH = 5,0 – 7,0 dan konduktifitas sebesar < 1,3 µS/cm.

 

 

 

 

3.        Jumlah total bahan aktif produk sebelumnya tidak boleh melebihi nilai Maximum Allowable Carryover (MAC).

Rumus perhitungan MAC oleh Haider, S I dan Asif, E S adalah sebagai berikut :



MAC = (TD X BS X SF)/LDD




Keterangan :

TD     : Therapeutic dose (mg)

BS     : Batch size terbesar produk selanjutnya (mg)

SF     : Safety Factor (0,001)

LDD : Largest Daily Dose produk selanjutnya (mg) à dosis maksimum

4.        Nilai ALT untuk kontaminasi mikrobiologi < 100 CFU/ml serta pengujian bakteri E. Coli dan Salmonella menunjukkan hasil Negatif (-).

 

Kesimpulan

            Validasi Pembersihan pada suatu mesin diperlukan dalam industri farmasi agar tidak terjadi kontaminasi silang antara produk satu dengan produk lainnya dalam melakukan proses pembuatan yang dilakukan pada mesin tersebut.

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Minum Teh Bikin Fokus

 

MINUM lima cangkir teh sehari bisa meningkatkan fokus pada orang yang berusia di atas 85 tahun, menurut studi baru di Newcastle University, Inggris. Dengan menggunakan data dari studi Newcastle 85+ yang melibatkan lebih dari 1.000 orang berusia di atas 85 tahun dari Newcastle dan North Tyneside, para peneliti mempelajari kebiasaan minum teh mereka. Hasilnya, mereka yang minum lebih dari lima cangkir teh sehari dengan atau tanpa susu tampil lebih baik pada tes kognitif tertentu. Dalam tes, mereka menunjukkan akurasi dan kecepatan reaksi yang lebih baik, yang dapat membantu dalam aktivitas sehari-hari seperti menjahit atau mengendarai mobil. (Daily Mail/Nur/X-10) (Media Indonesia 05/10/2021)