KAJIAN STERILITAS DAN ANALISIS RESIDU ETILEN OKSIDA DI DALAM ALAT KONTRASEPSI DALAM RAHIM

• Main Author: Sitompul, Erly
• Format: Theses
• Language: Indonesia
• Subjects: Farmakologi dan terapeutik
• Online Access: https://digilib.itb.ac.id/gdl/view/5241
• Institution: Institut Teknologi Bandung

<b>Abstract :</b><p align="justify"> <br /> Sterility test and analysis of ethylene oxide residue in intra uterinq device (IUD), a product of PT. Kimia Farma, Bandung had been carried out. Total microorganisms and their group from unsterilized samples were determined using plate count and staining Gram methods.<p align="justify"> <br /> Sterilityitest of sterilized samples were evaluated according to Farmakope Indonesia, edisi IV. Ethylene oxide residue in IUD was analyzed by gas chromatography with Porapak Q(R) column as stationary phase, nitrogen as mobile phase at flow rate of 30 mL/minute and 33 mL/minute and -flame ionization detector. Results showed that detection, quantitation, and determination limit for ethylene oxide were 7.7; 22.38 and I ppm, respectively, while recovery and variance coefficient for ethylene oxide in RID were 96% and 0.68% respectively. Total bacteria of unsterilized sample was 2.9 x 104 cfu/g, while total fungi was 3.9 x 104 cfu/g,-consisting of Bacillus and Sarcina and a group of fungi i.e Aspergillus All of the sterilized sample were sterile and ethylene oxide residue was not detected.<p align="justify"> <br />