Peralatan sensor empty pocket mesin pengemas dan alarm checkweigher PT Medifarma Laboratories memiliki kegiatan rekualifikasi kinerja yang terjadwal di periode 2023 atau setiap 5 tahun sekali. Rekualifikasi dilakukan dengan tujuan menjamin status peralatan terkualifikasi sesuai persyaratan, memantau hasil produk tetap terkendali jika tidak terdapat maupun terdapat perubahan pada alat, dan menjamin kualitas produk pada proses pengemasan. Rekualifikasi peralatan dilakukan dengan menyiapkan protokol, mengkoordinasikan jadwal rekualifikasi, melakukan dan mendokumentasikan hasil rekualifikasi peralatan oleh departemen Quality Assurance validasi dan kalibrasi, engineering dan produksi, serta menyiapkan laporan rekualifikasi. Berdasarkan hasil rekualifikasi kinerja, peralatan sensor empty pocket di mesin pengemas memenuhi spesifikasi kriteria keberterimaan pada parameter alarm berbunyi dan mesin mati secara otomatis pada setiap kantong strip yang kosong. Hasil parameter kualifikasi alarm checkweigher dalam mendeteksi berat corr box pengemas tersier juga memenuhi spesifikasi pada setiap kriteria keberterimaannya. Peralatan sensor empty pocket di mesin pengemas dan alarm pada checkweigher disimpulkan memenuhi kriteria keberterimaan dan peralatan masih berstatus terkualifikasi.
Empty pocket sensor for packaging machines and alarm on checkweigher at PT Medifarma Laboratories has performance requalification activities scheduled for the 2023 period or once every 5 years. Requalification is carried out with the aim of ensuring the status of qualified equipment in accordance with requirements, monitoring product results to remain under control if there are no or changes to the equipment and guaranteeing product quality during the packaging process. Equipment requalification is carried out by preparing protocols, coordinating the requalification schedule, carrying out and documenting the results of equipment requalification by the Quality Assurance validation and calibration, engineering, and production departments, as well as preparing requalification reports. Based on the performance requalification results, the empty pocket sensor equipment in the packaging machine meets the acceptance criteria specifications in the parameters of the alarm sounding and the machine turning off automatically for each empty strip pocket. The results of the checkweigher alarm qualification parameters in detecting the corr box weight of tertiary packaging also meet the specifications for each acceptance criterion. The empty pocket sensor equipment on the packaging machine and the alarm on the checkweigher were concluded to meet the acceptance criteria and the equipment still had qualified status. |
PR-Fenia3.pdf :: Unduh