Quality is not injected into the product through inspection, but is given by design. This advanced concept is used to support a range of pharmaceutical manufacturing processes and is included in the ICH guidelines to guide drug development1. ICH states a clear message about the manufacture of human drugs: quality can be designed. The principle of quality-derived design (QbD) approach is to establish quality in the production process through a clear understanding of the requirements of the production process, the risks involved and how to reduce the risk.
One of the biggest challenges in quality control during drug manufacturing is the risk of biological contamination. The production of drugs in a sterile environment is essential to ensure patient safety while maintaining production efficiency. Investigating the cause of a biofouling incident is a very time consuming and costly process. It is necessary to perform analytical tests to find the root cause of the accident, as well as to perform microbial identification and correction and preventive measures, and to control the batch of products that have been contaminated.
Careful design and planning of an effective disinfection procedure is a very necessary step. Finding new good sterilization solutions is indispensable in any pharmaceutical manufacturing process, especially as trends in drug development and regulatory enforcement change.
First, the advantages of hydrogen peroxide vapor (HPV) sterilization
There is an increasing demand for active biopharmaceuticals, and if terminal sterilization is continued, drug activity will be destroyed, so the demand for aseptic processing is increasing. The microbiological levels 2 required to be followed in the EU GMP Medical Drugs Directive 2 and the FDA Industrial Guidelines for Aseptic Processing of Sterile Drug Production 3 further drive the need for effective sterilization techniques.
Conventional manual wiping using detergents does not reliably achieve the reduction in bioburden (biofouling) levels specified in Appendix 1 of the guidelines. One of the solutions now is the use of hydrogen peroxide vapor (HPV) sterilization technology. In confined spaces such as isolators, transfer compartments or rooms, HPV can safely provide proven 6-log spore bactericidal effects. The HPV sterilization process can be verified using Bacillus stearothermophilus bioindicator 4, which typically achieves a 6-log microbial reduction in critical areas/surfaces and a 4-log microbial reduction in the surrounding environment (ie, microbes are reduced by 1,000,000 and 10,000, respectively) unit).
The best HPV technology combines a dedicated steam generator system with high-speed gas distribution to ensure uniform and even distribution of HPV in confined spaces. During the sterilization process, HPV is distributed on all surfaces to form a layer of micro-condensation (2~6μm, invisible to the naked eye) for rapid sterilization. Conventional disinfection methods using hand-wiping can make the surface of the object 'wet' and have residual disinfectant, potentially causing damage to the object. Conversely, the HPV sterilization process has a degradation phase in which HPV can be rapidly decomposed into water vapor and oxygen without any residue. HPV is flexible and compatible with a wide range of materials. Therefore, it can be used to disinfect sensitive electronic devices or hard-to-reach areas.
Second, HPV technology and QbD concept
An efficient, automated biological sterilization process (including critical control point monitoring in the process) is integrated into the pharmaceutical clean room to provide sterility assurance and to reduce microbiological monitoring points to increase efficiency and reduce costs. From commissioning to operation, HPV technology is suitable for the purification of pharmaceutical equipment, helping to increase production efficiency.
When designing a clean room, it is very meaningful to get advice from an early sterilization expert. While many systems offer installation flexibility, process efficiency improvements and cost savings can be achieved significantly if biosterive requirements and solutions are considered during the design phase.
An important pollution risk control point is the entry and exit of materials into and out of the clean room. Traditionally, high temperature autoclaves have been used for material delivery sterilization. However, due to the natural nature of heat and humidity, some materials cannot be used in high temperature autoclaves. For example, sensitive electronic devices or protein-based products can only be manually wiped and sterilized when transported into and out of the clean room, which is accompanied by a high risk of contamination.
HPV is compatible with a wide range of materials, providing a more thorough, verifiable and repeatable biological sterilization process for a variety of materials entering and leaving the clean room.
Many companies currently consider not only efficiency issues, but also environmental impact issues. High-temperature autoclave sterilization uses a lot of energy, so this method is not only inefficient, but also affects the environment. Alternative technologies such as HPV technology provide a fast and efficient sterilization cycle (a cycle of about 20 minutes), which is very efficient. Although HPV technology can be connected to existing pressure cookers, the use of HPV equipment in combination with the walk-in transfer cabin has a wider range of uses.
In order to meet the challenges of globalization and increase the competitiveness and diversity of products, more improvements are needed to improve the efficiency of pharmaceutical production. Biomass contamination is a key risk factor for product quality and productivity. The new sterilization technology, combined with best practices, provides sterility-assured design opportunities for the production and monitoring process, resulting in significant efficiency gains.
The need for disinfection and sterilization in cleanrooms varies widely, and HPV technology has proven to be a successful and comprehensive solution. Working with a manufacturer that offers flexible biological sterilization technology and extensive experience to meet individual customization needs for maximum efficiency.
references:
1. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (2009). ICHHarmonised Tripartite Guideline. Pharmaceutical Development Q8 (R2). CurrentStep 4 version dated August 2009.Switzerland, Geneva: ICH.
2. European Commission Enterprise and Industry Directorate-General (2008) EudraLex. The Rules Governing Medicinal Products in the European Union Volume 4. EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Annex 1 Manufacture of Sterile Medicinal Products (corrected version).
3. US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Office of Regulatory Affairs (ORA) (2004). Guidance for Industry Sterile Drug Products Produced by AsepticProcessing — Current Good Manufacturing Practice. Rockville, MD, USA: USDepartment of Health and Human Services Food and Drug Administration.
4. Parenteral Drug Association (PDA) (2010) Technical Report No. 51. Biological Indicators for Gas and Vapor-Phase Decontamination Processes: Specification, Manufacture, Control and Use. Bethesda, MD, USA: Parenteral Drug Association (PDA).
5. Drinkwater, J. (2010) Impact of QRM on RABS. CleanroomTechnology. Available online at http://[Accessed 16 September 2012].
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