Skip to main content

Biofilm Removal and Chemical Sanitization of RO Systems

 
Biofilm Removal and Chemical Sanitization of RO Systems

Sanitization of the reverse osmosis water purification system and biofilm removal from water system.

To control microbial growth, RO systems must be chemically sanitized on a regular basis. Prior to sanitation, it is important to chemically clean the first-pass RO system. This will help to disrupt any biofilm that protects viable bacteria from contact with the sanitant. It also removes foulants that will react with and chemically deplete the sanitizing agent.

Typically this is done in a two-step process. The first step commonly involves the use of an acid cleaner such as citric acid to remove the inorganic foulants. Next, a high-pH cleaner such as sodium hydroxide is used in order to remove organic foulants.

Then the system is sanitized with one of the following agents: formaldehyde, hydrogen peroxide, or peracetic acid/hydrogen peroxide. It is important to consult the manufacturer of the RO system to determine the correct concentrations of the chemicals that are compatible with the membranes in the system and always rinse with Purified Water before changing chemicals.

Both cleaning and sanitation processes consist of four steps. First, the cleaning chemical is mixed with permeate water in a clean-in-place (ClP) tank. Second, the chemical solution is recirculated through the RO system for 15 to 30 minutes. Then, the system is left to soak for 20 to 30 minutes. The system should be started once every 5 to 10 minutes for a short time to allow the fresh solution to contact the membrane. Finally, the system should be rinsed with permeate water until the residual cleaning and/or sanitation chemicals have been removed.

Although the second pass of the RO does not typically require cleaning as frequently as the first pass, a regular cleaning and sanitation schedule should be maintained. This schedule should be based on the microbial concentrations and samples collected from the permeate water from the second-pass RO machine. When microbial concentrations in the permeate begin to rise steadily, sanitation should be conducted.

If peracetic acid or hydrogen peroxide are used to sanitize PA membranes, the membrane must be cleaned with an acid cleaner in order to remove free iron and any other transitional metals; otherwise, the membrane may be chemically damaged by the sanitation procedure. It is also important to make certain that the sanitant is mixed with water that is free of chlorine. The membrane's exposure to the sanitant should not exceed one hour per week at the recommended concentration level, or reduced membrane life may occur.

Related: Bio-contamination Control Techniques for Purified Water System

Biofilm Removal

Biofilm is a common term used to describe the accumulation of micro-organisms and their by-product excretions onto surfaces of a water treatment system. Because most micro-organisms prefer to become attached to a surface, more and more micro-organisms will adhere to the surfaces of a water system. As micro-organisms die, they become nutrient sources for other micro-organisms.

Over time, a film consisting of living and dead organisms will form. A slimy cover called a glycocalyx surrounds the organisms and serves to trap nutrients from the water source and protect the organisms from chemical destruction and biofilm removal.

Related: How to Remove the Pathogenic Bacteria from Water Systems

For biofilm removal, it is necessary to conduct a series of sanitation and cleaning steps. First, inorganic should be removed using a low-pH cleaner.

Second, any organic compound or dead micro-organisms should be removed using a high-pH cleaner such as sodium hydroxide. Third, sanitation should be conducted using a common sanitizing agent such as formaldehyde, chlorine, or peracetic acid/hydrogen peroxide.

Then conduct a series of organic cleaning cycles followed by sanitation cycles. Prior to changing chemicals, always flush with purified water. For severe, established biofilms, it may be necessary to repeat this process 5 to 10 times. During each step, the sanitation agent should be in contact with the system for 15 to 30 minutes for an effective biofilm removal.

Also see: Purified Water System Validation

Comments

Popular posts from this blog

Checklist for Audit in Sterile Area

Checklist for Audit in Sterile Area Checklist to verify the sterile manufacturing area before the audit. 1. Is there any SOP giving details for activity/ movement in the sterile area. 2. Verify the suitability of system for sanitization of hands. 3. Is there the SOP on entry-exit; gowning and de-gowning into the critical area available? 4. Verify the availability of following records:  Air pressure differential  Particulate monitoring  Temperature  Humidity  Microbiological monitoring by settle plate 5. Are these records available and maintained as per SOPs? 6. Check the above mentioned individual records. Are the entries within specifications mentioned in SOP/ MTPs. 7. Is the controlled copy of MTP pertaining to monitoring by settle plate available to plant person? 8. Are the location for settle plates identified and the chart/ layout available with plant? 9. Are the following areas monitored for parameters mentioned in step 4:  Air-lock to the critical ar...

Aseptic Filling Process (Media Fill) Validation Protocol in Sterile Pharmaceuticals

Aseptic Filling Process (Media Fill) Validation Protocol in Sterile Pharmaceuticals Validation of sterile manufacturing process by media fill validation test as per PICS guidelines for aseptic validation or aseptic process simulation. 1.0 OBJECTIVE 1.1 To define procedures for validating and maintaining the validation of all aseptic filling processes and qualification of the quality of the product by system/facility/equipment. 2.0 SCOPE 2.1 This procedure applies to all aseptically filled sterile products intended for human use. 3.0 RESPONSIBILITY 3.1 The Validation personnel coordinate the aseptic filling validation program and write the sterile media aseptic filling processes reports. 3.2 Manufacturing personnel the sterile media aseptic filling processes and performs the sterile media fills. 3.3 QA personnel perform the sampling and assist with the IPQA monitoring required for each sterile media fill. 3.4 QC personnel to perform the testing and assist with the monitoring required fo...

Blow Fill Seal (BFS) and Form Fill Seal (FFS) Technology in Sterile Manufacturing

Blow Fill Seal (BFS) and Form Fill Seal (FFS) Technology in Sterile Manufacturing Know about sterile pharmaceutical production using Blow Fill Seal (BFS) and Form Fill Seal (FFS) technology. Both of these techniques are used to manufacture  sterile pharmaceutical products   as parenteral (LVP & SVP), infusions, ophthalmic and inhalation products. These are automated techniques to prepare sterile products. The basic concept of the  FFS   and BFS is to reduce the  contamination   by forming the container, filling and sealing in a closed sterile chamber of the machine. There is no personnel intervention to reduce the chances of the contamination during the manufacturing of sterile products. It gives more production at very low operational cost with the high assurance of  sterility . Blow fill seal technology is widely used and accepted by the various pharmaceutical regulatory authorities as US-FDA and MHRA. The system is being used for over 30 years a...