SteriPack Contract Manufacturing supplies the medical & pharma industries and offers ISO Class 8 cleanroom moulding/cleaning/assembly and packing of medical & drug-delivery devices.
Our locations (Ireland, Poland, USA and Malaysia) are cGMP/ISO13485/FDA compliant.
Capabilties include: - Contract Engineering (Design&Development) - Process Integration - Validations and Testing (in ISO 17025 accredited laboratory) - Contract Regulatory Adivse - Supply Chain Management - Contract Manufacturing (injection moulding, cleaning, filling, blistering) - Product Packing - Sterilisation
Quality & Compliance ˘ ISO 13485:2012 Compliant to MDD 93/42/EEC, Annex II ˘ FDA registered and audited 21 PART 820 Quality System Regulation compliant ˘ Pharmaceutical Manufacturing Authorization for primary and secondary packaging (cGMP) ˘ CAN/CSA ISO 13485:2003 ˘ Accredited to MHLW Japanese Ministerial Ordinance No. 169 ˘ CE marking ˘ 510K submission ˘ ISO 17025 Accredited Laboratory ˘ Class ISO 7 and 8 Cleanroom production ˘ Humidity and temperature controlled manufacturing environment