Astro Pak’s Disinfection, Sanitization & Biofilm removal chemistries and processes are proven to remove both biofilm accumulations and bioburden that are migrating within the systems and equipment.
Astro Pak has a wealth of experience and success in resolving the sanitization and disinfection needs of bio-burdened critical systems. Rouge removal and UltraPass® passivation are important services that work in tandem with sanitization to address bioburden growth. Our sanitization chemistries remove oxidation of bioburden cells and eliminate contamination to the level of disinfection or sterilization. Disinfection during pre-commissioning of new systems or after shutdowns can prevent future contamination issues. Astro Pak’s consultants and scientists are experts in providing guidance and data interpretation that ensures long term control for persistent issues.
Astro Pak’s fleet of vehicles, mobile skids, equipment and chemicals allow us come onsite to meet your disinfection and sanitization needs. We routinely respond to emergency situations for critical utilities, systems and equipment on site or in our shops located nationwide. Our Certification packages are QMS/cGMP compliant for your systems and equipment maintenance records. We also can process tubing, fittings, and other components in our shops located nationwide. Immediate response for emergency outages and critical utilities is routinely provided.
What Industries Need Biofilm or Bioburden Removal?
There are numerous industries that require biofilm and bioburden removal. The following list shows some typical and representative industries:
- Food and Beverage
- Medical Devices
- Household Personal Care
- Life Sciences
- Water and Wastewater
- Aviation & Space
How Can Astro Pak Help Remove Biofilms?
Effective removal of biofilms in water systems typically requires a series of cleaning and sanitization steps. It is always necessary to evaluate the system or equipment to determine what is present that requires removal, i.e. inorganic compounds such as iron, organic material including sloughed-off biofilm or dead micro-organisms, and biofilm colonies, before treatment is initiated.
Each system is unique. Hence, Astro Pak formulates distinctive and unique Disinfection, Sanitization and Biofilm removal chemistries and processes for each client. These chemistries have been proven highly effective in removing both biofilm accumulations, and bioburden that is migrating within systems and equipment. Specific sanitization chemistries remove bioburden bacteria and eliminate contamination to the level of disinfection of sterilization. Disinfection during pre-commissioning of new systems or after shutdowns can prevent or mitigate future contamination issues. Depending on the size of the stainless steel system or equipment in need of treatment, cleaning and sterilization can be performed on-site or at a specialized facility.
What Is a Biofilm?
Biofilms are defined as bacterial populations which adhere to surface interfaces on stainless steel components of water systems. Biofilms can adhere to stainless steel surfaces in the presence of water in a matter of a few seconds to a few minutes. Once the bacteria adhere themselves to a surface, and excrete an exopolymer (glycocalyx) slime layer, the biofilm is distinct from planktonic microorganisms in the water system and quickly develops into a colony. The slime layer protects the rapidly growing colony of bacteria from environmental changes due to temperature and chemistry. The slime layer concentrates nutrients under sparse conditions to fuel the growth of the biofilm colony and attract secondary or other species of bacteria that coexist in a symbiotic relationship.
How and Where Do Biofilms Exist?
Surfaces such as RO membranes, DI resins, storage tanks, filters and piping systems all provide surfaces that are suitable for bacterial growth and attachment. Even in well maintained water systems, biofilm can form. In new systems, biofilm formation can be related to the diameter of the pipe, the velocity of circulating water, or the presence of dead-legs. In established water systems, biofilm formation is associated with shutdowns or periods of low water flow, or after repairs and maintenance. It should be noted that even if water flow is turbulent in the center of a pipe, the flow velocity can decrease to near zero at the pipe wall in laminar flow conditions. The distance from the pipe wall in which the flow rate is not turbulent is called the laminar sublayer, and this is the area that the biofilm populates by affixing to pipe walls.
Why Are Biofilms Difficult to Remove?
As biofilms change with time and mature, it becomes increasingly difficult to eradicate them. The thickness of the biofilm increases to an optimal thickness based on the environment. As the bacteria profile in the biofilm becomes more diversified, the biofilm inhabitants can become more resistant to chemicals because different species of bacteria can exchange genetic information including plasmids which encode the information for bacterial resistance to specific chemicals. The biofilm constitutes a highly effective defense barrier. No single chemical is effective in completely reducing or eliminating mature biofilms. Thus, different mechanisms of actions (MOA) are required to eradicate well-established biofilms because of their chemical resistance.
Effective treatments require specialty chemical mixtures tailored to the wetted materials and bacterial species which have been identified. Adjunctive chemicals which enhance the cleaning chemistry can also be added to the chemical protocol to disrupt the bacteria from carrying out functions that enable bacteria to construct the biofilm structure.
Monitoring for Biofilm and Bioburden
While chemical analysis usually generates answers quickly enough to ensure a rapid response to problems, microbiological assessment is often slower and less accurate. Most microbiological assessments of pharmaceutical-grade water rely on culture-based methods, although rapid microbiological methods are gradually being implemented (such as ATP bioluminescence* or fluorescent DNA-specific dyes). This means bioburden results are not available until several days have elapsed. In addition, water samples only collect free-floating (planktonic) bacteria and cannot measure the quantity and extent of existing biofilms. Free-floating bacteria that are measured have been sloughed off the biofilm, or are bacteria passing through the system from the incoming water supply system. Therefore, monitoring trends versus time from microbiological plate-based cultures are critical in evaluating the severity of biofilm contamination within a system.
Biofilm and Bioburden for PW and WFI Systems
Both Purified Water (PW) and Water for Injection (WFI) systems need to be assessed for bioburden and biofilms. WFI systems may also require endotoxin testing analysis, depending on the industry. Bioburden in-process testing of pharmaceuticals is critical to understanding the types and amounts of microorganisms in the product during the manufacturing process. The assay is a regulatory requirement for the manufacture of sterile products under the U.S. Code of Federal Regulations (CFR) 21CFR.
While utilization of hot water flushing (80°C) is often considered acceptable in order to minimize planktonic contaminants (free floating bacteria) and some immature biofilms, it is not effective in removal of established (mature) biofilm masses present in water systems and must be supplemented by chemical treatment and sanitization processes.
Surface Quality, Biofilm Activity and Microbiologically Influenced Corrosion (MIC)
An inspection of microscopic surface profiles reveals the surface roughness that is generated by corrosion and the formation of rouge. A roughened and rouged surface also can lead to increased biofilm activity, since any surface roughness provides for easier attachment of bacteria to the substrate. It is common for a rouged system to require more frequent sanitization cycles to maintain bioburden control.
The physical presence of microbial (bacterial) cells on stainless steel surfaces and their metabolic activities can cause microbiologically influenced corrosion (MIC) on the stainless steel surface, in addition to other corrosion mechanisms. Formation of a biofilm on the stainless steel can result in differential aeration cells and oxygen depletion under a biofilm. This will promote pitting corrosion on stainless steel surfaces.
A protective passive layer of chromium oxide on stainless steel surface layers will inhibit and/or decrease surface corrosion, rouge formation and corrosion initiated by microbial mechanisms (MIC) associated with biofilms in water systems. Removal of rouge from a system that is promoting bio growth is critical to maintain a bacteria-free surface. Therefore, rouge removal by Astro Pak using derouging chemistries, followed by an UltraPass passivation process for optimizing corrosion resistance, is an important service that works in tandem with sanitization to address bioburden growth.