Containment Systems and Aseptic Processes

Containment systems

Definition of “CONTAINMENT”
The overview of the functions and operations carried out in the chemical and pharmaceutical industry is always based on 3 basic elements:

• the product
• the personnel (operator)
• the surrounding environment

The concept regarding “containment” derives from this simple consideration, which is the set of physical structures and activities that can isolate the first (product) from the other two elements.

Market references: amount of toxic products treated in the pharmaceutical industry, market size and trends

The global situation of the leading pharmaceutical and chemical industries indicates that the number of active toxic products, “Potent drugs”, currently in production is around 95% of the total. With reference to solely the cytotoxic sector, a turnover of 9.6 billion dollars is estimated in the 7 major markets. A growth of up to 11.3 to 12.8 billion dollars by 2014 is forecast and the United States ranks first with over half the total sales.

Transferring systems and containment technologies (examples based on Comecer products)

The key element for this evolution is the understanding and use of containment technologies that can reduce the risks posed to operators and the environment.
Thanks to the decades of experience in the radiation protection sector in Nuclear Medicine applications, Comecer has been able to make use of the know-how acquired in using the technology of the isolators (glove boxes) by adapting and transferring it to the pharmaceutical sector, thereby proving to have a marked advantage with respect to others who have only recently approached such technologies. The vast range of products in the Comecer portfolio can meet all the Containment requirements, whilst guaranteeing the highest standards of quality and a complete development process, from the preliminary design to the validation of the equipment.

The Modular Dispensing and Weighing Isolator was specifically created to mainly satisfy the requirements related to the handling process of highly toxic API (Active Pharmaceutical Ingredients). Its modular structure together with the highly flexible integration of process instruments (vacuum ovens, reactors, scales, filters, milling, etc.) were and still are the reasons behind it being the market leader for this type of application. In order to complete the basic machines that are then, more often than not, customised to meet specific process requirements, Comecer has gained a wealth of experience in Cross Contamination Control as well as the material transfer strategies, both in and out of the contaminated area. In fact, the many different applications have allowed for experiments and an in-depth understanding of the philosophies behind pre-chamber use, RTP (Rapid Transfer Port), Continuous Liners, etc.

Aseptic processes

Another critical and constantly evolving aspect in the pharmaceutical sector is the need to protect the product from contamination due to the presence of personnel or the environment. In fact, that which matters most in pharmaceutical aseptic processes is the maximum reduction of the risk of product contamination, guided by the basic requirement of guaranteeing patient safety. Such contamination is basically due to particles, micro-organisms and endotoxins. The two main defences against these threats are processes with terminal sterilisation and aseptic processes.

Definition of “ASEPTIC PROCESS” and the distinction (advantages and disadvantages) from final sterilisation (terminal)

Less attention is paid when preparing the components in processes that involve terminal sterilisation and handling the components is simplified, however, the product must have characteristics of resistance to thermal stress. Moreover, this type of production normally occurs in batches and therefore, in a non-continuous manner, thereby requiring accumulation and process phases and spaces.
In the aseptic processes (the second), the preparation, product and handling are very critical phases, which require ad hoc procedures, special and validated instruments and equipment. The first target is “respect” for the product, maintaining it at optimal temperatures and avoiding any type of contamination from external agents.

Available aseptic process technologies (Clean-room, RABS and Isolator) and comparative analysis

There are currently three types of technologies available for aseptic processes to be set-up and managed:

• Standard clean-room: a dedicated and closed off room, kept in controlled conditions, having certain reproducible requisites that maintain the air at a given particle and microbiological classification degree (Class A – ISO 5). If the advantage is to improve accessibility to the process machines and the product, on the other hand there lies a high risk of SAL failure (Sterility Assurance Level), rather high energy consumption related operation costs as well as a complication in the operator dressing procedures
• RABS (Restricted Access Barrier System) is a physical and aerodynamic protection for the product, which maintains Class A within and limits the operator’s access to the critical area. However, the surrounding environment must be classified as Class B
• Isolator: the isolator (or glove box) represents the maximum level of protection against the risk of product contamination, thanks to its main characteristic that physically “isolates” the critical area and requests transferring systems based on high containment technologies. A definite advantage is that of being possibly installed in a Class D laboratory. This type of solution is often obligatory when the product that is to be handled in asepsis is even toxic.

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