Personnel are a significant source of contamination in aseptic manufacturing, and reducing human intervention in critical zones is essential to ensure the sterility of finished goods. Isolators and RABS (Restricted Access Barrier Systems) work to control contamination during pharmaceutical production. Because these systems are equipped with a variety of sophisticated protections and physical barriers, they protect the operator from harmful chemicals and safeguard the product from pathogens and other particulate contamination. For a manufacturer, choosing the right barrier system is important to meet the needs of the particular product being made and the facility. 

Complete and absolute ingress control is essential to aseptic processing and is essential to ensure an improvement over traditional open cleanroom processing. RABs have unidirectional airflow enclosed in a rigid wall enclosure with glove port access where necessary. The interior of the enclosure is manually sanitised with sterilised equipment and parts introduced using aseptic procedures which can include transfer systems. All product or process contact parts within a RABS are sterilised or Steamed-In-Place (SIP) prior to use. Although doors can be opened, this happens rarely, after which appropriate line clearance and cleaning must occur per procedures. 

Isolators are fully enclosed and sealed units with HEPA-filtered air supplied in a unidirectional manner to the working environment. Completely closed isolators may be supplied with either turbulent air or unidirectional air. Air is typically recirculated by returning it to the air handlers through sealed ductwork. The chamber is bio-decontaminated via an automated cycle using H2O2 or another sanitant and all access is through glove ports and sterile transfer systems. All items entering the system after bio-decontamination are pre-sterilised. 

RABs offer much lower capital expenditure and can be retrofitted into an existing facility. They can be used for everyday multiproduct manufacturing as well as requiring less qualification effort. They are easier to adapt coming from a conventional cleanroom. However, they have a lower sterility assurance level and involve high running costs. They are also not recommended for highly potent chemicals as operator intervention is possible, putting them at risk.

Isolators have the highest sterility assurance level and can be used for longer, having more retention of the equipment and environment for a defined number of batches. They can be used safely with highly potent products and provide convenience for the operators as well. They have lower running costs and save cleanroom space which is helpful when it is already limited. However, they require high capital investment and need long bio-decontamination times. It is also far harder for operators to manually intervene if needed. Isolators also require the development of an H2O2 cycle for decontamination, which will need to be validated as a process.

Syntegon is the Silver Sponsor of our upcoming event, the ‘3rd Aseptic BioPharma Processing Summit’, where professionals and industry leaders will come together to discuss best manufacturing techniques as well as innovations and challenges facing the aseptic processing industry. Syntegon has decades of experience in the design and manufacture of RABS, isolators, and complete production lines, with references from all over the world. They offer you a unique integration approach – ranging from the isolator itself, to the bio-decontamination and air-handling technology to the qualification and validation of the entire system – all from one source. 

To understand which barrier system is best for your aseptic processing needs, join Syntegon and many other solution providers and esteemed speakers from across the industry at the Innovatrix ‘3rd Aseptic BioPharma Processing Summit’ in Vienna, Austria, on October 29–30, 2024.

For more information, visit our website or email us at info@innovatrix.eu for the event agenda.