Sanitation, Passivation and/or Sterilization of new and existing equipment and piping systems is a critical step in your system’s performance and reliability. Options to achieve proper results include 1. chemicals such as pericitic acid, peroxide, chlorine, 2. ozone, 3. heat.

Whether part of a scheduled maintenance protocol or done after a major overhaul, the cleaning of your system is a delicate process. Ultrapure offers three basic services:

Sterilization: "to render sterile, or to make free from ALL live bacteria or other microorganisms. A total kill of everything". May use a combination of heat and chemicals. 

Sanitization: "to render sanitary, or free from elements, such as filth or pathogens, that endanger health. This does not mean ALL possible microorganisms, etc., but MOST. Sanitizing does not remove ALL bacteria, microorganisms etc.".  A cleaning of your loop, system, or part may be done to flush your system in between schedule sterilizations.

Passivation: is a chemical cleaning and chemical change to stainless steel piping or parts that removes greases and oils and also promotes a passive layer between the internal pipe material and the solution that passes through the pipe. This procedure has many applications in various industries to include but not limited to pharmaceutical, biotech, bio med, and food and beverage.

Additional Information 
Sample Sanitization Protocol

This site-specific information is to be coupled with the general overview of sanitization information for proper use of, and the primer for Minncare disinfectant. Please refer to the Fibercor / Minntech paperwork included in this packet.

I. Preparation for Sanitization

  • Schedule shut down of loop with production/ compounding
  • Have sanitization skid and minncare on site
  • Safety meeting on site prior to starting work
  • Turn off reverse osmosis unit

II. Concentration of Solution

  • Drain storage tank with blowdown valve to 1000 gallons with loop pump running
  • Turn off UV lamps
  • Add 10 gallons minncare sterilant to storage tank
  • Recirculate for 15 minutes
  • Using minncare 1% test strips check concentration of solution
  • Check concentration and add minncare solution as needed to reach and maintain a 1% concentration

III. Time of Circulation

  • When concentration levels stabilize at 1% for 2-15 minute readings circulate for 2 hours
  • Under some circumstances (when system is extremely bio-fouled) an additional 2 hour static soak - leaving solution in system without circulating
  • Check concentration at regular intervals to maintain 1% concentration level
  • After static soak circulate solution for 15 minutes
  • Dump solution to drain

IV. Rinse Out Procedures

  • Turn off loop pump
  • Add dechlorinated city water to storage tank (approx. 100gal) 
  • Start loop pumps
  • Turn on UV lamps
  • Open dump valve to drain and continue filling storage tank with dechlorinated city water
  • Check concentration of solution with residual test strips at filter housing and both POU drops
  • Continue flushing to drain and adding dechlorinated city water until all test points read less than 1 ppm residual on test strips
  • Drain down system using pump and blowdown valve until pump loses prime - shut off pump
  • Open drain on bottom of tank and drain residual dechlorinated city water from tank
  • Shut off UV lamps
  • Turn reverse osmosis unit on with switch in auto position and allow to make up to approximately 1000 gallons
  • Purge air from pumps and filter housing and UV units
  • Turn on UV Lamps
  • Start loop pump
  • Check POU drops with residual test strips to confirm that all minncare has been rinsed from system
  • Flush additional 500 gallons to drain using blowdown valve
  • Return system to normal auto mode

 

Sample Sanitization Protocol pdf

Sample Passivation Protocol

Passivation of Stainless Steel Piping

The purpose of this paperwork is to describe the standard operating procedure for cleaning and passivation of stainless steel piping used in the UPW, pharmaceutical, and food and beverage industries. The following areas will be detailed: 

I. Swab Passivation of Weld Areas
II. Passivation of 316 Stainless Steel Piping
III. Neutralization of Passivation Solution
IV. Rinse Down Specifications
V. MSDS and Other Safety Issues
VI. EPA / Chemical Handling and Rinse Down / Release to Drain
VII. *Addendum 1.1 – Dip Passivation

* Where the terminology for RO / DI water is detailed Hot Purified Water and / or Hot WFI water can be substituted per customer SOP requirements.

Read the details of the sample protocol of passivation of stainless steel piping.