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10 Steps to Prepare for Commissioning and Qualifying your Cleanroom

by Gerbig in General Cleanroom. Comments Off on 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:

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?
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 … Read More »

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

by Gerbig in General Cleanroom. Comments Off on 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 … Read More »

How to Manage Cleanroom Data for FSMA Compliance Part 2

by Gerbig in General Cleanroom. Comments Off on 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:

 

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 … Read More »

How to Manage Cleanroom Data for FSMA Compliance Part 1

by Gerbig in General Cleanroom. Comments Off on How to Manage Cleanroom Data for FSMA Compliance Part 1

There 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 … Read More »