One of the most problematic issues of aseptic manufacturing is the involvement of personnel. Human presence generates millions of particles every minute. Some of these particles are biologically active and can generate product contamination. Now, technology can create a revolution by removing human intervention from the aseptic manufacturing process to reduce its impact on product sterility. Stainless steel GMP robotic arms have been introduced to handle fill finish operations within a gloveless isolator. The advantage of this process, apart from sterility improvement, is the possibility of handling Highly Potent Active Pharmaceutical Ingredients (HPAPIs) like cytotoxic drugs in a flexible and cost-effective way. This article goes through all the main features of the gloveless robotic solution and describes a cluster tool concept for an advanced aseptic production facility.
Aside from the usual challenges of traditional blockbuster drugs, on which patents provide a crucial period of exclusivity and protection, the new era of the pharmaceutical industry has been facing expiring patents and a consequent increase in R&D expenditure addressing also a rapidly growing demand for anti-cancer drugs. The largest number of ongoing clinical studies focus on cancer treatments and half of the newly developed anti-cancer drugs are injectable. Additionally, bio-pharma research is generating new higher value/ lower volume drugs, many of which are highly active. The key drivers for 2020 are related to high value niche therapies and personalized drugs that will require smaller batches, shorter runs, process flexibility and greater process complexity. Increasing quality expectations in this more volatile demand are expected to drive the market towards lower risks, shorter time to market and increased cost-effectiveness.
Since the operator still plays an important role in aseptic manufacturing, glove boxes, isolators and RABS can be considered a simple solution to segregate the processing environment and improve Grade A continuity and SAL (sterility assurance level).
However, the environment is presumed to have a greater chance of actually being sterile if the operator is not present.[…]
A courtesy of ‘Clean Air & Containment Review’ – www.cleanairandcontainment.com
- author: Mauri Sergio