Containment Systems: Sources of Security and Improved Business

In the global pharmaceutical industry, containment systems represent one of the major technological advances of the last three decades. The manufacture of molecules in aseptic environment has moved from the era of control of human contamination to the era of control of automated systems. This phenomenon was initiated by precursors who had the awareness to implement technologies from the energy industry and microelectronics industry then growing at that time.
The first containment systems showed the beginnings of a technology in the making. Sterilization systems and containment systems were the subject of lengthy and costly studies and the materials were unsuitable for the intended use. It is thanks to the implementation of these containment systems for toxic products that the growth of insulators and other RABs (Restricted Access Barrier systems) have been realized.

The pieces of the puzzle
Containment systems are not just boxes that prevent operators in manufacturing areas from intervening directly in critical areas. It is precisely the mistake of the pioneers of this technology to believe that these systems were just that. Containment systems are in fact an aggregation of several technologies known to pharmacists in charge of sterile production for years:
1. Air treatment
2. Containment of infertility
3. Sterilization of environments

It can be seen from this operating diagram that technologies and ways of working in a confined environment are in perpetual questioning. What is important to understand is that in thirty years we have moved from an aggregated technology model to an integrated technology model. Most insulator and RABS manufacturers have realized the need for mastery of air treatment technologies and sterilization of environments.
It is no longer about patches on a standard equipment but rather a completely integrated filling or packaging machine in a well-managed and globally thought-out ergonomic work environment.
for aseptic manufacturing.
In fact, this integration now represents an alternative to conventional aseptic filling processes in ISO 5 cleanroom environments. The financial constraints of the initial capital investment are being reduced more and more because of the standardization of this equipment by the manufacturers and the generalization of the processes in order to increase the sterility assurance of the products.

Financial consequences
What a paradox to have a request from the global health infertility insurance agencies to 6 logs for insulators while operators do not have access to the critical area, when conventional work environments do not have a demand for sterility assurance that 3 logs without recommendation as clear as for containment systems!
Yet all manufacturers have understood that the implementation of modern containment systems now represent an increase in their profitability and a reduction in operating costs as well as contamination problems. A Johnson & Johnson presentation was already done in 2006 at the Barrier System User Summit in Collegeville, New Jersey (USA)
showing that investment in this type of technology was about 40% heavier than conventional RABS technology but that operating costs were lower than 40% per year. This study was conducted by A4P Biarritz workshop 3 in 2011 and the result shows a strong reduction of this gap. Indeed, the workshop highlights a difference in the investment of only 15% in favor of conventional RABS but a return on investment of 1,6 year for insulators due to operating costs.
Source: Pierre Fabre CDM

Conclusion:
As technology progresses, containment systems represent an interesting alternative that gives manufacturers of sterile pharmaceuticals, unparalleled sterility assurance and becomes a safety factor for production. This is due to the increasing control of this technology both by users but also by manufacturers.
The standardization of equipment at the manufacturers and the integration of sterilization and air treatment technologies increase the potentiality of these systems to become the standard of the pharmacy manufacturing methods of the future sterile products that will be placed on the market. However, the agencies and players in this industry need to consider containment systems not as a system for protecting human contaminants but as more an integrated handling system now the critical filling area in a controlled environment.

SONY DSC

Franck PAVAN - PIERRE FABRE CDMO

franck.pavan @ pierre-fabre.com

Bibliography

  • FDA Guidance for Sterile Drug Products Produced by Aseptic Processing / Current Good Manufacturing Practice - September 2004
  • Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac PH Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac Pharmac PH PH PH PH PH PH PH PH PH PH PH PH PH PH PH PH PH PH PH PH PH PH PH PH PH PH
  • 34 PDA Technical Report No. 2001: Design and Validation of Isolator Systems for the Manufacturing and Testing of Healthcare Products - September / October
  • Acceptance Criteria In the Validation of VPHP Decontamination Dr. James E. Akers / A3P 22nd Congress, October 2010

And as for the congresses:
?? A3P Biarritz 2011: 4 Workshop No.

2006 - Collegeville, NJ, USA - Isolators and RABS: Evolution, Devolution, and Revolution - The Edwards from Advanced Barrier Process USA and John Chester