VALIDASI
( VALIDATION )
Edward Andre Meide Saputra Pardede, Jella Iranda, Reza Amelia Octaviani,
Yasrina
Pharmacy Study Program Faculty of Mathematics and Natural Sciences Sriwijaya
University Indralaya
ABSTRAK
Validasi merupakan sebuah kegiatan untuk melakukan pembuktian, artinya validasi adalah
sebuah pekerjaan atau bisa juga disebut sebagai dokumentasi. CPOB mensyaratkan industri
farmasi untuk mengidentifikasi validasi yang perlu dilakukan sebagai bukti pengendalian
terhadap aspek kritis dari kegiatan yang dilakukan. Perubahan signifikan terhadap fasilitas,
peralatan dan proses yang dapat mempengaruhi mutu produk hendaklah divalidasi.Validasi
adalah tindakan pembuktian dengan cara yang sesuai bahwa tiap bahan, proses, prosedur,
kegiatan, sistem, perlengkapan atau mekanisme yang digunakan dalam produksi maupun
pengawasan mutu akan senantiasa mencapai hasil yang di inginkan. Percobaan yang
dilakukan berupa validasi autoklaf, validasi oven, validasi kimiawi dan validasi timbangan.
Dari percobaan ini, dapat diketahui bahwa pada validasi oven pada suhu 200C selama 30
menit valid dapat mensterilkan alat gelas dan logam.
Kata Kunci : validasi, oven, autoklaf, timbangan analitik
ABSTRACT
VALIDATION OF STERILIZATION
2.3 Procedure
METHODS
Calibration
Validation Method Sterilization with
Calibration Scales analytic Autoclave
Do it Weighing child Scales standard, then Set it up container Preparations Form bottle
Record results weighing, repeat Weighing up to infusion, vial, and ampoule, then Preparations
5 times the count value - average, tolerance Inserted Aquadest and Inserted to in Autoclave
difference weight which is still could be with a temperature of 121 * C for 15 minutes,
accepted that is for weight of 1-50 mg: preparation do on box aseptic, remove
0,014mg, 100-500 mg: 0.025 mg, 1-5 mg: Preparations from Autoclave and Make sure
0,054 mg. Then count range of values tolerance still Spared from contact air Outside to Sign in
on weight child Scales and Count difference into the box aseptic, Sterilization Aquadets in
value - average weighting with weight child each container in check with the media in order,
scales. with dripping sufficiently and flattening,
incubation agar medium containing Sample
Calibration Autoclave
preparations 24 hours, check there is at least
Do it Testing microbes that are Thermophilic growth Bacteria on an agar medium.
and have Endospores that is Bacillus
stearothermophilus. Media for inclusion to in Validation Chemical
Autoclave and sterilize, incubation 24 hours Rinse cap vial with alcohol 70%, then Rinse
ago Observe growth Bakter when the media with distilled water, then sterilization Aquadest
remains clear then Autoclave work with good. checked with the media in order, with dripping
sufficiently on surface and leveling her, then
Calibration Oven
Incubated 24 hours, check there is at least
Prepare the media to be put into the oven and growth bacteria on an agar medium.
incubate for 24 hours, then observe the growth
of bacteria on the media. Validation Method Sterilization with Oven
A. The result of sterilization test of gray 1 broth medium in all group A tool is smaller
group shows that the infusion sterilization than Group B value D. Because the sterilization
tested with the media for chicken broth, as well process with autoclave by group A is more
as sterilization of all the tools tested with the sterile than group B.
BIBLIOGRAPHY
LAMPIRAN