|PRODUCTS||SERVICES||KNOWLEDGE CENTER||CUSTOMER SUPPORT||OUR COMPANY|
Particle Measuring Systems Nordic
Sweden Phone: +46 761 959 616
The BioLaz Real-Time Microbial Monitor provides real-time detection of biological organisms in controlled environments used for the manufacture of sterile products. (read more...)
Our products and services are designed to help you improve yield, detect the presence of contaminants, and meet regulatory requirements by:
Whether you want to protect product or meet industry requirements, such as ISO 14644, ISO 21501, USP 797, ISO 14698, or GMP, Particle Measuring Systems has a large variety of particle counters, microbial air samplers, and molecular monitors to meet your needs. With over 35 years experience, we have proven particle counter reliability to support your application. Our workforce is well-educated and highly trained to support your particle counting, microbial air sampling, or molecular contamination application. As the inventors of laser-based particle counting technology, we offer the most complete range of particle counters to meet your needs.
Protect your product with our reliable laser particle counters. We have a complete line of monitors for air and liquid particle counting. Our air particle counters monitor from 0.06 - 25 microns. We have portable and handheld particle counters, particle sensors for trending, particle spectrometers for research, and particle counter manifold solutions.
Our liquid particle counters include solutions for a wide variety of applications including DI water, inline chemicals, batch sampling chemicals, pharmaceutical injectable solutions, small volume sampling, and parts cleanliness testing. With reliable particle counter sensitivity as low as 0.05 microns, we are the leader in liquid particle counting.
Molecular contamination creates costly problems to high value products, production processes, and equipment surfaces. We have solutions for both Airborne Molecular contamination (AMC) and Surface Molecular contamination (SMC). With parts-per-trillion limits of detection, real-time sampling, NIST traceable calibrations, and various data analysis packages, you can monitor in confidence.
Our AMC monitors use Ion Mobility Spectrometry (IMS) to provide you with real-time reliable results at ppt sensitivity. This provides continuos protection of products from costly damage.
Improving particle counting and molecular contamination monitoring is a time-consuming task. Particle Measuring Systems offers a complete line of particle counting and molecular monitoring services to help you. Rely on our expertise and our full range of particle counters to find particle sources, characterize processes, or to monitor particles in cleanrooms. With over 35 years of application experience and expertise, we are the world leader in particle counting. We offer the most complete range of services including Lab Testing, Site Testing / Troubleshooting, Training (including Particle College), Airborne Molecular Contamination (AMC) Testing, and Installation and Validation of particle counters for pharmaceutical cleanrooms.
The GMP guidance for sterile manufacture was revised in 2003 to accommodate changes from various cleanroom standards to create a single unified cleanroom standard, ISO 14644-1. The introduction to ISO 14644-1 states this as:
"Annex 1 of the EC Guide to Good Manufacturing Practice (GMP) provides supplementary guidance on the application of the principles and guidelines of GMP to sterile medicinal products. The guidance includes recommendations on standards of environmental cleanliness for clean rooms. The guidance has been reviewed in the light of the international standard EN/ISO 14644-1 and amended in the interests of harmonisation but taking into account specific concerns unique to the p3roduction of sterile medicinal products."
To summarize, the method to certify a cleanroom needed to comply with the rules and format of ISO14644-1 particle counting guidance; this new annex includes a modified ISO standard which addresses sterile medicinal products. To support this, a table of cleanroom certification values that roughly translated to ISO 14644-1 was defined. For clarity, a series of notes appended the table. Unfortunately, the first, "Note a", caused certain confusion.
This confusion has been remedied in the 2008 release of the EU GMP Annex 1 which clearly outlines three phases that need to be performed:
Table 1: download pdf for table
To perform the required particle monitoring certification it is important to understand ISO14644-1 and how to certify a cleanroom in accordance with that standard, rules on number of particle counter sample points, particle counter sample point location, and volume of particle sample to be taken at each location, along with the rules on statistical analysis of cleanroom data that need to be followed. However, rather than use the table for classification limits prescribed in ISO14644-1, you should be using the table shown in Table1, as printed in the revised guidance document.
Other expectations are also defined by the GMP, such as the particle counter sample volume for Grade A, which should be 1m3 per sample location, and that a minimum length of sample tubing should be used due to the high precipitation of 5.0 µm particles in transport tubing. Ideally, no sample tubing should be used. Also, recertification of the cleanroom should follow the guidance given in ISO14644-2. That is, once per year for ISO Grade 6 and greater, and once per 6-months for ISO Grade 5 and cleaner; concessions are made for extending the ISO Grade 5 areas if a particle monitoring system has been implemented. Suitable times to perform particle counting certification are media fills, or simulated filling runs.
After the cleanroom or clean air device has been certified, the room must be monitored, relative to risk, to prove that the aseptic manufacturing environment can be maintained, and proven to be maintained. Particle Measuring Systems has published several papers regarding the types of system suitable for monitoring based upon risk and how to implement such systems.
The Grade A zone, which is the environment of greatest potential risk to the finished product, should be monitored for particles for the full cycle of production, including set-up. The frequency of particle counting should ensure that any interventions, short duration events, or general deterioration in conditions be measured and alarms triggered if alert/action limits be exceeded. This requirement of all events essentially precludes the use of particle counter manifolds in these areas due to the sequential nature of the sampling being performed; concessions are made for the use of particle counter manifolds if they have been sufficiently validated as suitable for the relevant manufacturing type.
Grade B areas follow the same rules as Grade A. However, the frequency of particle counter sampling can be reduced. Grade A is maintained under laminar flow, and so short burst events may be localized and of a very short duration, excluding some catastrophic failures. However, Grade B is turbulent mixed air flow and reflective of the general environment in which the operators occupy. A low level of continuous particle activity in this area is normal and the particle counter system response is to alarm when general control of this area is out of tolerance. Therefore, an immediate spike in particle contamination is less likely to have a significant impact on product quality. This becomes more pronounced when looking at background support areas beyond the zone in immediate proximity to the filling line or other Grade A areas.
In the 2003 GMP, there was confusion over the particle counter sample required for monitoring the Grade A and Grade B areas due to the phraseology used. The 1m3 sample was to meet the calculation required by ISO14644-1 and not a risk based monitoring value. However, clarity is provided in the revised guidance: