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"[ABSTRAKLatar belakang. Sepsis neonatorum awitan dini (SNAD) adalah sindrom klinisakibat respon sistemik terhadap infeksi pada awal kehidupan. Diagnosis SNADseringkali sulit karena gejala klinisnya tidak spesifik.Tujuan. Mengetahui sensitivitas dan spesifisitas biakan usap telinga dalamdiagnosis SNAD.Metode. Subjek penelitian adalah neonatus yang lahir di RSCM Jakarta dan RSUTangerang Selatan dengan diagnosis SNAD. Dilakukan pengambilan biakan dariusapan telinga dan darah bayi.Hasil. Diantara 50 subjek, terdapat 2 neonatus dengan biakan darah positif, dan 32neonatus dengan biakan usap telinga positif. Hanya 1 subjek yang memilikikesesuaian jenis kuman yang tumbuh dari biakan darah dan biakan usap telinga.Bakteri yang tumbuh pada biakan usap telinga sebagian besar adalah Gram postif(62%). Biakan usap telinga mempunyai sensitivitas 64,7%, spesifisitas 36,4%,nilai duga positif 34,3%, nilai duga negatif 66,6%, rasio kemungkinan positif1,02, rasio kemungkinan negatif 0,97, dan, akurasi 46% untuk mendeteksi SNAD.Simpulan. Ditemukan hasil biakan darah positif pada 2 subjek. Biakan usaptelinga memiliki sensitivitas 64,7%, spesifisitas 36,4%, nilai duga positif 34,3%,nilai duga negatif 66,6%, rasio kemungkinan positif 1,02, rasio kemungkinannegatif 0,97, dan akurasi 46% untuk mendeteksi SNAD.

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ABSTRACTBackground. Early-onset neonatal sepsis (EOS) is a clinical syndrome due tosystemic response to infection in early life. EOS is often difficult to diagnosedbecause the clinical symptoms are not specific.Objective. The study aim to determine sensitivity and specificity of ear swabsculture in the diagnosis of EOS.Methods. Neonates born in the CMH Jakarta and Tangerang Selatan Hospitalwho developed sepsis were studied. Swabs were collected for culture from baby’sear. Bacterias isolated from ear swabs cultured were correlated with those fromblood culture.Results. Among 50 neonates studied, 2 neonates had positive blood cultured and32 neonates had positive ear swabs cultured. Only one subject had suitabilitytypes of bacterias that grew from blood and ear swabs. Bacteria grew from earswab cultured were predominantly Gram-positive (62%). Ear swabs cultured hadsensitivity 64.7%, specificity 36.4%, positive predictive value (PPV) 34.3%,negative predictive value (NPV) 66.6%, positive likelihood ratio (PLR) 1.02,negative likelihood ratio (NLR) 0.97, and accuracy 46% to detect EOS.Conclusions. This study showed positive blood culture results were found in twosubjects. Ear swabs cultured had a sensitivity 64.7%, specificity 36.4%, PPV34.3%, NPV 66.6%, PLR 1.02, NLR 0.97, and accuracy 46% to detect EOS, Background. Early-onset neonatal sepsis (EOS) is a clinical syndrome due tosystemic response to infection in early life. EOS is often difficult to diagnosedbecause the clinical symptoms are not specific.Objective. The study aim to determine sensitivity and specificity of ear swabsculture in the diagnosis of EOS.Methods. Neonates born in the CMH Jakarta and Tangerang Selatan Hospitalwho developed sepsis were studied. Swabs were collected for culture from baby’sear. Bacterias isolated from ear swabs cultured were correlated with those fromblood culture.Results. Among 50 neonates studied, 2 neonates had positive blood cultured and32 neonates had positive ear swabs cultured. Only one subject had suitabilitytypes of bacterias that grew from blood and ear swabs. Bacteria grew from earswab cultured were predominantly Gram-positive (62%). Ear swabs cultured hadsensitivity 64.7%, specificity 36.4%, positive predictive value (PPV) 34.3%,negative predictive value (NPV) 66.6%, positive likelihood ratio (PLR) 1.02,negative likelihood ratio (NLR) 0.97, and accuracy 46% to detect EOS.Conclusions. This study showed positive blood culture results were found in twosubjects. Ear swabs cultured had a sensitivity 64.7%, specificity 36.4%, PPV34.3%, NPV 66.6%, PLR 1.02, NLR 0.97, and accuracy 46% to detect EOS]"

"Industri farmasi badan usaha yang melakukan kegiatan pembuatan obat atau bahan obat dan telah memiliki izin sesuai ketentuan peraturan perundangundangan. Dalam proses produksi obat, industri farmasi harus mengacu pada Cara Pembuatan Obat yang Baik (CPOB) dan validasi harus dilakukan pada seluruh tahapan kritis proses produksi serta ketika terdapat perubahan signifikan dalam proses produksi. Salah satu validasi yang dilakukan oleh PT. Harsen Laboratories adalah validasi pembersihan, yang dilakukan untuk membuktikan efektivitas prosedur pembersihan peralatan yang digunakan dalam produksi serta kontak dengan produk. Validasi pembersihan dilakukan pada mesin oscillating granulator terhadap zat aktif loperamid hidroklorida pada produk tablet lopamid. Analisis kajian risiko dan penetuan marker, dilakukan berdasarkan tingkat kelarutan, dosis terapeutik terkecil, dan nilai toksisitas LD50. Penentuan MACO (Maximum Allowable Carry Over) dilakukan untuk mengetahui analytical swab dan rinse limit. Validasi pembersihan dilakukan dengan dua metode yaitu rinse (bilas) dan swab (usap) untuk setiap parameter pengujian fisika, kimia, dan mikrobiologi. Hasil validasi menunjukkan parameter pengujian fisika, kimia, dan mikrobiologi metode usap dan bilas memenuhi kriteria penerimaan yang dipersyaratkan.

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Pharmaceutical industry is a company that carried out drug or drug ingredient manufacturing process and has obtained a license in accordance with the provisions of laws and regulations. In manufacturing process, the pharmaceutical industry must refered to Good Manufacturing Practices (GMP) and validation must be carried out at all critical stages of the production process and when there are significant changes in the production process. One of the validations carried out by PT. Harsen Laboratories is a cleaning validation, which is carried out to prove the effectiveness of cleaning procedures of equipment used in production as well as contact with products. Validation of cleaning is carried out on the oscillating granulator machine against the active substance loperamide hydrochloride in lopamide tablet products. Risk assessment analysis and marker determination were performed based on solubility, smallest therapeutic dose, and LD50 toxicity value. Determination of MACO (Maximum Allowable Carry Over) is carried out to determine the analytical swab and rinse limit. Cleaning validation is performed by two methods, rinse and swab, for each physical, chemical, and microbiological test parameter. The validation results showed that the physical, chemical, and microbiological test parameters of the swab and rinse method have met the required acceptance criteria."