Whitepaper aseptic filling
Aseptic filling: Technological Evolution: Taking Primary Packaging to the Next Level
Technological developments in the pharmaceutical industry have advanced rapidly over the last decades. One field of particular interest has been aseptic and sterile primary packaging. Primary packaging of pharmaceutical products often involves filling containers (including vials, syringes and bottles) with powders and/ or liquid solutions. Manufacturing staff, equipment and premises are all subject to stringent quality controls – and for good reason: patient safety.
In order to ensure the safety and quality of pharmaceutical products, every manufacturer in the pharmaceutical industry is compelled to adhere to the Good Manufacturing Practice (GMP) guidelines, first published in 1989. Recently, a complete draft revision1 of Annex 1 (Manufacture of Sterile Medicinal Products) of the GMP has been released. This document intends to provide information on the latest status, trends and technologies in parenteral filling equipment.
Executive summary :
Primary packaging in the pharmaceutical industry includes aseptic and sterile filling of all sorts of medicinal dosage forms and with rapid developments in the fields of technology and personalized medicine, the need for flexible production options is notably growing.
Requirements of Primary Packaging Equipment
The use of injectable biologicals demands extreme precision, due to their high potency and cost. For highly accurate and controlled filling and weighing, proven and reliable technology and equipment prevents costly overfilling, thereby increasing production efficiency. In addition, packaging needs to be compatible with the ingredients to minimise the risk of interaction and to maximise cost-effectiveness and efficiency.
Compliance Challenges in Pharma
Manufacture of pharmaceutical sterile products is always subject to requirements of the GMP and its Annexes, including the “Annex 1 Manufacture of Sterile Medicinal Products guidelines”, which is centred around three key points: Quick Response Manufacturing, Personnel, and Quality Assurance. In addition to being GMP compliant, aseptic/sterile Fill-Finish equipment solutions need to be dependable and accurately designed to comply with the most recent revisions of Annex 1.
Inno4Life Filling Expertise
Through combined decades of experience in developing primary packaging equipment, the Inno4Life engineers are capable of delivering custom and fully compliant machinery to every customer. To this end, Inno4Life applies a structured R&D trajectory which includes thorough reviews and risk assessments in every step. Inno4Life operates in co-design taskforces with experts to come up with turnkey filling equipment and containment solutions for any aseptic grade.
Read all about it and download the full white paper about aseptic filling trends and technologies here.
Find out more about the Inno4Life Filling equipment solutions, designed to simplify the pharmaceutical primary packaging process. Equipment that meets all your specified requirements and complies to global and local regulations.
For additional detailed information, we invite you to contact the Inno4Life filling equipment experts.