Lean 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 … Read More »
Cleanrooms 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 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, … Read More »
One 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 … Read More »
Validation 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.
Pharmaceutical 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 … Read More »