10 Steps to Prepare for Commissioning and Qualifying your Cleanroom

Compliance in a cleanroom relies on proving you have good engineering practices (commissioning), and verifying facility/systems aspects that affect product quality (qualification). Carrying out these verifications can be quite overwhelming. John R. Butterfield describes each process in cemag.us’ “Commissioning and Qualification of Existing Facilities.” He also offers advice on how to prepare your facility for each.

Here is a 10-step summary of how you can plan for commissioning and qualifying your cleanroom facility:

  1. Outline objectives. Before you begin, you want clearly defined objectives for the process. Why are you commissioning/qualifying? Are both required? What are your business’ needs? Why? What is the goal/where do you want to end up?
  2. Identify stakeholders. Your stakeholders need to be involved in your process. They should offer feedback on the objectives, and commit to the plan. Identify who they are across operations, engineering, maintenance, quality, compliance, and security.
  3. Create a plan draft. To develop an initial plan, ask your stakeholders where you are today, where you want to be, where the gaps are, what it will take to reach objectives, key factors for success, cost, schedule, and resources.
  4. Hone the scope of the program. Your first draft will need to be refined according to funding, schedules, and resources. Use impact assessments and risk assessments to determine how to refine your scope to still achieve key objectives and maximum benefits.
  5. Put together a project team. Use consultants, contractors, stakeholders, and anyone else who can coordinate project activities.
  6. Kickoff. You need to hold a project kickoff meeting to:
    1. Introduce the team and stakeholders
    2. Identify everyone’s roles/responsibilities
    3. Establish communication channels
    4. Explain facility operating, safety, and security requirements
    5. Go over program objectives
    6. Review the plan and scope
    7. Confirm team and stakeholder commitments
  7. Compile documentation. Collect the relevant existing documentation, like drawings/specs, policies, SOPs, manuals, and records.
  8. Update documentation. Update the information you have and fill in any gaps.
  9. Execute your commissioning and qualification. With your user requirements defined, functional specifications developed, and detail design docs created, you can now carry out pre-functional, functional, and performance testing.
  10. Follow-up. Maintain accurate/updated documentation, and transfer completed documentation to the stakeholders.

By taking the time to plan, gather resources, and execute testing, compliance is easier for you and your team. If you have questions about cleanrooms, validation, or certification, contact Gerbig Engineering Company at 888-628-0056 or info@gerbig.com. We’ve expertly handled cleanroom equipment and services since 1985.

Cleaning Ceramic Tile Floors in the Cleanroom: Mop or Spray-and-Vac?

When it comes to cleaning your ceramic tile floors, the greatest challenge lies in cleaning the grout. Grouting is softer, more porous, and set lower than the tiles. The smaller your tiles, the more grout surface you have, making the process more difficult. It would seem pretty obvious that a spray-and-vac method of cleaning is more effective than mop cleaning, but by how much?

The answer comes from data given by Jay Glasel, Ph.D. in his cemag.us article, “Cleaning Methods for Ceramic Tile Floors.” In the study that Glasel presents, the mop cleaning method was tested against the spray-and-vac method. Here is a summary of the study.

Bacterial counts were taken on the test floors before, during, and ten minutes after cleaning/drying using three different solutions. The solutions were:

  • Water alone
  • “A mild, multipurpose, pH neutral, cleaner that combines citrus d-limonene with hydrogen peroxide was used at a dilution of 2 oz/gal in tap water for cleaning tests using this agent.”
  • “A hospital grade broad spectrum, pH neutral disinfectant was used at a dilution of 2 oz/gal in tap water for cleaning tests using this agent.”

When using water alone, the mop was able to remove about 50% of bacteria, and the high flow fluid extraction removed almost 90%.

When using a multipurpose cleaner, the mops effectiveness was about the same as with water alone. The spray-and-vac machine, however, removed all but 1% of the bacteria.

With the hospital grade disinfectant, mopping removed slightly more bacteria than it achieved using water or household cleaner. The spray-and-vac, while already extremely effective with the multipurpose cleaner, was 2% more effective with the disinfectant.

In the end, the study concluded that mopping has a cleaning efficiency of 38% while the spray-and-vac cleaned with 98% grout cleaning efficiency. It is worth noting that theoretically, mops could achieve the same efficiency as the spray-and-vac method. However, this would likely involve aggressive agitation, longer dwell time, and increased mopping/rinsing. The extra time and effort would translate into higher costs, taking away the one advantage mopping had in the first place.

For questions about cleanroom certification and verification, contact Gerbig Engineering Company. We’ve expertly handled cleanroom equipment and services since 1985. Contact us at 888-628-0056 or email info@gerbig.com.

How to Manage Cleanroom Data for FSMA Compliance Part 2

Food production cleanrooms have to comply with the Food Safety Modernization Act. This entails establishing HACCP-based written Preventive Control Plans. Without a paperless system, this is a truly labor-intensive project.

 

Having a laboratory information management system (LIMS) can be a huge help in managing your cleanroom data and complying with HACCP. Hazard Analysis and Critical Control Points uses seven principles to outline its risk mitigation and hazard prevention process. Last week we covered the first three principles and how a LIMS can assist with each. Today we will focus on the remaining four:

 

  1. Monitoring procedures. The third principle was establishing critical limits; once these are set, you need to establish monitoring processes for each. Your LIMS can fully automate data collection and transmission throughout your organization. You can generate reports based on historical data and the LIMS will alert staff when critical limits are exceeded.

 

  1. Corrective actions. In the case a critical limit is exceeded, you have to have a clearly defined process of correcting the issue. Your LIMS can provide your standard operating procedures and walk staff members through the designated response to each error. Colin Thurston’s “Managing Data in Food Safety Cleanroom” article in cemag,us explains:

 

“Assume, for example, that a piece of monitoring equipment connected to the LIMS detected that the condition of a cleanroom air filter had deteriorated to an unacceptable level. The LIMS could then alert the cleanroom staff and provide them with an automated SOP for replacing or cleaning the filter, saving time and ensuring that the job is done correctly. Additionally, the LIMS makes audits by senior staff and regulators easier by recording which staff member performed the corrective action.”

 

  1. Verification procedures. Cleanroom monitoring instruments can fall out of calibration. Using this equipment will give you an inaccurate reading on product quality. Therefore, you need to regularly verify instrument performance. Your LIMS can store instrument maintenance schedules and alert managers when it’s time for maintenance.

 

  1. Recordkeeping procedures. With a LIMS, recordkeeping is simple and efficient. All data going in and out of the system is automatically recorded. Internal and external audits are therefore accurate and reliable. With digital recordkeeping, you can also easily trace the origin of error. This saves a lot of time, energy, and money when resolving an issue.

 

Overall, LIMS helps food manufacturers in a number of significant ways. It helps store and retrieve vital information for HACCP compliance, adds security to your system, and can reduce the scope and cost of a recall operation. It provides the simplest way to establish your Preventive Control Plan. For questions about cleanrooms, validation, or certification, contact Gerbig Engineering Company at 888-628-0056 or info@gerbig.com.

How to Manage Cleanroom Data for FSMA Compliance Part 1

equipment_validation_mainThere is no question how important cleanrooms are to food and food supplement production. The integrity of the product(s) depends on continuous monitoring of multiple cleanroom variables. This monitoring process creates large amounts of data, and managing that data ensures the effectiveness of the whole system.

For food production cleanrooms, one of the most reliable data management systems is the laboratory information management system (LIMS). According to Colin Thurston’s cemag.us article, “Managing Data in Food Safety Cleanrooms,” a LIMS “manages highly complex and integrated laboratory operations (such as SOPs, methods, and workflow) as well as integration of all instruments for sample management, data collection, reporting, and archiving. The LIMS also connects the laboratory to other enterprise systems, giving management real-time information about the health of the lab and giving the organization the flexibility to demonstrate compliance with any regulatory requirements as needed.”

Those in the food production industry should also be familiar with the FSMA, which requires food producers to establish HACCP-based written Preventive Control Plans. Without a paperless system, following strict adherence to the HACCP requirements can be extremely labor-intensive.

Here is how a LIMS can help with the first three of HACCP’s seven principles of risk mitigation and hazard prevention process:

  1. Hazard analysis. All materials that pass through a facility should be able to be traced back to their point of entry. You can do this by creating a database of materials suppliers in your LIMS. The manufacturer must also pinpoint hazards, including where materials are added, product extracted, vessels opened, and final products packaged. These locations can then be mapped in the LIMS.
  2. Critical control points. These include any point in a food production process where checking quality can prevent food safety hazard in the end product. All of these CCPs can be stored in your LIMS. As Thurston said, “Storing control points in the LIMS also greatly increases a cleanroom’s flexibility and scalability; adding a new point or modifying an old one is simple when the facility’s data management system is fully digital.”
  3. Critical limits. All control points need a clearly defined critical limit. This is any level, condition, or point that, when unmet, can result in serious damage to the final product. A LIMS will allow food producers to identify samples that are outside of the acceptable range so they may be removed from any outgoing shipments.

These first three steps will help you start on integrating your LIMS with your Preventive Controls Plan. In our next article, we will cover monitoring, corrective action, verification, and recordkeeping. For questions about the Food Safety Modernization Act’s rules, see FSMA section 103, entitled “Hazard Analysis and Risk-Based Preventive Controls.”

For questions about cleanroom certification and verification, contact Gerbig Engineering Company. We’ve expertly handled cleanroom equipment and services since 1985. Contact us at 888-628-0056 or email info@gerbig.com