Lean Manufacturing in the Cleanroom

wwd clnrmLean is one of the most popular principles applied in the manufacturing industry today. Developed within the Toyota Production System, these concepts are now widespread throughout all manufacturing sectors. The basic concept is to eliminate anything that does not add value, or that which is waste. Waste comes by way of materials, efforts, and time. A lean operation is streamlined and flexible, and can absolutely be applied to the cleanroom.

Lean principles can be applied to both future and existing cleanrooms. Here are some guidelines:

  • Strategic location (new cleanroom): consider everything that goes into the entire process of making and delivering your product. What kind of supplies do you need? What kind of storage? Who are your customers? How will your product be transported? What future needs will you have? Selecting a location that is close to suppliers, warehouses, major transportation and the like can significantly cut time and cost from your future operation.

 

  • Building and cell layout (new cleanroom): while these are two separate plans, each can be constructed according to lean guidelines. For the building, Look at all the factors that you can’t change, like zoning and operability (e.g. drainage, power) requirements. For anything in the building these predetermined constraints effect, plan your layout around them.

 

  • For the cell layout, consider how you can optimize the time it takes to complete each task involved in each step of the process. Can you create a work cell around a piece/pieces of necessary equipment so that workers don’t have to move from room to room?

 

  • Workstations (new and existing cleanrooms): consider how to make each workstation mistake-proof, organized, and, when possible, intuitive. Additionally, evaluate all ways that contamination can be prevented or removed. Eliminating excess cleaning saves a lot of wasted time. Similarly, carefully select cleaning products and train employees on how to use them. Over cleaning can compromise the surface structure, creating more problems.

 

  •  Communicate effectively with suppliers and customers (new and existing cleanrooms): know exactly what your customers need, and communicate that to your suppliers. Create standardized, transparent processes that are in agreement with your clients’ needs and suppliers’ capabilities. Make sure everyone is on the same page.

 

For each individual manufacturer, evaluate what activities waste the most time, whether they’re related to accidents, space restrictions, miscommunication, or whatever else does not add value to your process. Once these activities are identified, you can plan a strategy to eliminate them.

Gerbig Engineering Company experts can help you construct a cleanroom that meets your lean needs. We can also discuss validation and certification requirements to keep you in compliance with specific standards.  Planning ahead is part of the lean process, too.

Proper Monitoring of the Cleanroom Environment: Reminders

Softwall-Gownroom.jpgCleanrooms have to meet all relevant regulatory requirements that are mandated for the products being manufactured. These are agencies like the Institute of Environmental Sciences and Technology (IEST) and the International Organization for Standardization (ISO).

In order to ensure continued compliance, manufacturers need to understand what environmental factors cause contaminates, and they need the proper equipment to test for them. Here are a few reminders for your cleanroom plan.

First and foremost, remember that personnel produce the most contaminates in a controlled environment. In addition to covering people with proper garments, keep in mind:

  • Personnel should practice good personal hygiene
  • If anyone has a skin or respiratory condition, he or she should not work in the cleanroom until it clears up
  • The risk of human flora contamination increases when people perspire, so ensure that the temperature is not too hot
  • Shivering releases microbes into the air, so the temperature can also not be too cold

 

To ensure that surfaces meet sterility requirements, they need to be tested for environmental flora. There are two methods to accomplish this:

  • Contact plates. These are used on flat surfaces. The media filling the plates creates a dome. The surface of the media is pressed against the surface being tested. The plates are incubated, and any colonies present are counted.
  • Swabbing. Swabs can easily reach nooks, crevices, and other irregular surfaces. They are typically made of cotton, synthetics, or calcium alginate materials. The sterile swab is moistened with a non-nutritive medium and swiped in several directions over the test area. The swab is placed in a rinse solution and then agitated. The collection medium is then tested for its microorganisms.

 

Proper cleaning materials are also necessary to maintain an environment that meets all regulatory standards. Be sure that you have chosen cleaning supplies that work with the class of your cleanroom. Some supplies include:

  • Mops and buckets
  • Vacuum cleaners
  • Wipes
  • Brooms
  • Sponges
  • Squeegees
  • Disinfectants
  • Cleansers
  • Shoe cleaners

 

Once a cleanroom is built, it still needs to be maintained to ensure that manufactured materials are not compromised. It is the manufacturer’s responsibility to monitor the cleanroom environment and provide proper training for workers.

Need certification or validation for your cleanroom? Gerbig Cleanrooms does both.  Contact us today.

What a Closed-Loop System does for the Cleanroom

LIGO Structural CeilingOne of the most important elements of a cleanroom environment is the flow and control of air. This is crucial to retain filter efficiency as well as keep humidity at a desired level. There are a few kinds of fan filter systems available for cleanrooms. Controlled environments that don’t have closed-loop systems can create challenges for cleanroom workers that drive costs and waste energy.

Many laminar flow stations use something like an AC Drive Manual Control with a flow monitor and an alarm that goes off when the air is not at an acceptable level. Cleanroom workers manually handle the fan speed in a couple of ways. If the system has a particle counter so that workers can monitor contaminate levels, they will manually adjust the fan speed throughout a shift as levels change. If workers over or under-adjust the fan, they can be fidgeting with it several times throughout a shift. This method takes a toll on productivity and is not energy-efficient.

If cleanroom workers can’t monitor particle counts, many will keep the fan filter units running on high day and night. This also is a drain on energy and can cause filters to become blocked.

What a closed-loop system does is both measure the environmental levels and control/adjust the fan speed accordingly. Workers can set the sensors to the levels that are required for their particular cleanroom. As the system detects changes in the levels, it automatically adjusts the fan speed. These systems:

• Ensure that the cleanroom airflow and particle count is always within required parameters, even when no one is around
• Uses only the amount of energy needed at any given time, reducing costs and energy consumption
• Improves productivity – no one needs to monitor the system or manually adjust the fan
• Prolongs the life of the filter

Additionally, some systems are also able to post reminders for validation scheduling, control lighting, and differentiate between day and night controls.

In the past, closed-loop systems were expensive and complicated to implement. Now, however, systems are available with a variety of features; choosing one without a lot of extras will bring costs down. Additionally, many are made so that setup is easy. In the long run, spared energy and productivity ensure a reasonable return on investment. Talk to a cleanroom expert like Gerbig Engineering Company to decide whether a closed-loop system is right for you.

The Core Elements of the Validation Master Plan

validation_1Validation is documented evidence that declares a process or system will consistently meet a predetermined specification. It is a series of documented tests and gathered information that proves a system will produce a product that meets all specifications and standards. Validation is FDA-mandated for the pharmaceutical, bio-pharmaceutical, medical device, and food manufacturing industries.

The facility using the system is solely responsible for validation. While it is common for a facility to contract  an outside firm to perform this complex service, it is still the facility’s obligation to approve protocols and execute testing. Ensuring that the entire validation process is accounted for requires some organization. This comes by way of the validation master plan.

The master plan maps out the entire process of validation. It is thorough and multifaceted. A full description of a master plan can be found here in Jan Eudy’s “Validation of Aseptic Cleanrooms for Co-Packing Food Items” in Controlled Environments.

The validation process can be summarized, however, into four core specification areas:

  • Installation Qualification (IQ) – this documentation is a series of checklists, forms, drawings, schematics, and equipment manuals that prove all devices, equipment, and control loops are installed and functioning as specified. Any hardware and software that controls the equipment is included in this category.
  • Operation Qualification (OQ) – this documents that all equipment and accompanying control systems operate as designed and perform within specified standards.
  •  Performance Qualification (PQ) – This puts the entire process together to ensure that the final product consistently meets specifications. Eudy describes it: “The PQ documents that the entire system can operate consistently and will produce a product meeting the predetermined specifications of the facility.”
  • Change control – this documents any change that has been performed as well as the revalidation of the changed element and the entire system working after the change has been implemented.

Firms that perform validation have outlines of a validation master plan and expertise in completing all the necessary steps. It is often more convenient and more reliable to call upon an expert to validate a cleanroom. Gerbig Engineering Company performs validation of facilities and equipment. A detailed description of what their IG, OQ, and PQ entails can be found on this site under Services > Validation > IQ, OQ, PQ.

The Present and Future of Cleaning Cleanrooms

Integral prefilterPharmaceutical industry experts predict an evolution in cleanroom cleaning between now and 2020. They speculate that materials, techniques, and even guidelines used to clean will all look different. However, the current state of the industry suggests that cleanroom workers are not even up to par in cleaning for today’s standards. This matter urgently needs to be addressed. Barbara and Ed Kanegsberg tackled this issue in their Controlled Environments article, “2020 Pharma.”

The Kanegsbergs call upon the expertise of Paul Pluta, Associate Professor of Biopharmaceutics, College of Pharmacy at University of Illinois, Chicago and Editor in Chief of the Journal of Validation Technology and the Journal of GXP Compliance. Pluta points out what he knows people are doing wrong the pharmaceutical industry:
• Not determining their worst case compound
• Not identifying the actual residue on the equipment
• Using uncontrolled concentration of cleaning agents in water
• Using illogical cleaning agents
• Cleaning equipment to pass validation rather than in a consistent manner

Those who are guilty of the above are going to have an extremely difficult time meeting requirements when guidelines change and more monitoring is implemented. Considering the evolution of drug resistant organisms, lax cleaning practices are not just obstacles, but great safety concerns.

So how does a company turn this around?

One important place to start is the expert and pay level of the people doing the cleaning. The article states, “‘Who cleans the floor?’ asks Pluta. ‘The lowest one on the totem pole. That should change. We have to say: ‘We will train you. We will have competent personnel do the training. We will pay you appropriately.’ That would be fantastic!’”

Proper training is not just about the proper way to clean; it is also about explaining the importance of the job. Investing in personnel, including onsite trainers, backs the idea that the cleaning responsibilities are great ones.

Another change to make immediately is to have a cleaning plan. Pluta suggests following the FDA lifecycle approach: “Lifecycle means 1) proper design and development of the cleaning process; 2) proving it works by validation; and 3) maintaining the process by periodic review of performance. By this method, deficiencies will be noted and continuous improvements should occur.”

A cleaning process should be controlled and monitored. Employees should collect data on temperature, time, concentration, and rinse water conductivity. This should all be part of the cleaning process design.

The pharmaceutical industry can look forward to some distinct and effective changes over the next six years. Companies can only move forward, however, if they are operating at the current expected standard. Failure to improve the cleaning process now will jeopardize business in the fast-approaching future.

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