With You Every Step Of The Way
In order to comply with EN 1422 – EN ISO 11135, ISO 13485 Standards, and GMP guidelines, our protocols and procedures are created to help you comply with validation requirements and meet your requirement specifications.
URS (User Requirement Specifications)
Definition of requirements to fulfill the demands of the process. Generally, URS is required for eto sterilizer machine before making the design.
In order to meet the user requirement, we pay special attention to the URS (User Requirement Specifications) (such as chamber size, product, package, EO percentage, etc.)
Issued by: User
FDS (Functional Design Specifications)
Spesifikasi dimana tuntutan pembeli dialihkan ke dalam solusi teknis (dari sudut pandang produsen)
Dikeluarkan oleh: Produsen
SPESIFIKASI DESAIN (DS)
Spesifikasi dasar teknis dan spesifikasi faktor pembatas yang harus diperhatikan selama pengembangan, konstruksi dan perakitan. DS memastikan bahwa semua persyaratan pelanggan dan standar valid terkini dari CGMP, UE, EN ISO, dan FDA terpenuhi.
FAT / SAT (Tes Penerimaan Pabrik/Tes Penerimaan Lokasi)
Tes penerimaan terdokumentasi di pemasok/pelanggan dengan log pengujian, ringkasan pengujian, daftar masalah terbuka, dan sertifikat rilis.
In BOCON, before the sale, the factory provides customers with the design and consultation on the overall equipment and facilities of the ETO workshop and assists in the formulation of the overall planning and layout of the ETO workshop. According to the characteristics of the customer site and product, material, packaging, transportation, and future development, we choose the material, configuration, control mode, volume, and quantity for the sterilizer. To assist in the preparation of the ethylene oxide sterilization process, verification scheme, ETO workshop management rules and regulations, equipment use and maintenance, etc. At the same time to provides relevant standards, preheating, residual analysis, processing technology consultation, and cooperation.
DQ, IQ, OQ, PQ
DQ (Kualifikasi Desain)
IQ (Kualifikasi Instalasi)
OQ (Kualifikasi Operasional)
PQ (Kualifikasi Kinerja)
Mulai dari spesifikasi produk dan persyaratan, hingga analisis risiko, hingga perencanaan dan pelaksanaan langkah-langkah kualifikasi individu, kami menangani semua yang diperlukan dalam implementasi.
Validasi: BOCON akan menyediakan validasi perangkat lunak. IQ, laporan OQ, dan dukungan PQ setelah instalasi.
Laporan IR OQ PQ
