The Particle Count Newsletter – Airborne Particle Counting for Pharmaceutical Facilities; EU GMP Annex 1
On February 14th, 2008, The European Commission updated Volume 4 EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Annex 1: Manufacture of Sterile Medicinal Products. This update comes into operation on March 1st, 2009. (With the provisions on capping of freeze- dried vials implemented by March 1st, 2010)
Cleanroom Requirements, Certification and Monitoring Per Common Accepted Standards
Cleanroom Classification and class limits are established in ISO 14644-1 (see Table 1), while specifications for testing and monitoring to prove continued compliance are established in ISO 14644-2 (see Tables 2 and 3). Often there is confusion regarding the definitions of certification and monitoring. This article explains the differences between monitoring and certification.
Continuous Particle Monitoring
In order to determine the best system for continuous monitoring of particles in a cleanroom, you should understand the two types of continuous particle monitoring systems. Real time particle monitoring involves the use of a single particle counter or particle sensor at a specific location. This sensor is dedicated to monitor particles only at this specific location. Every event would be detected and counted. There are no gaps in the particle counting data. Particles are monitored in particles per cubic foot or particles per cubic meter. This system is best used at critical locations where events can happen at any time. Critical or very sensitive operations can be monitored.
How to Select a Particle Counter for my Cleanroom
Often, the selection of a particle counter for use in a cleanroom is done based upon the specifications of the instrument and the purchase price. Before getting into the details of the specifications, it is important to look at how the instrument will be used, the environments in which it will be used and who will be using the instrument. Without this information taken into consideration, a less than optimal choice of particle counter for the application could be made.
Lighthouse Worldwide Solution’s SOLAIR 1100+ Laser Tube Lifetime
The Lighthouse SOLAIR 1100+ particle counter has been designed to achieve superior laser life performance in a HeNe based laser particle counter. This extended lifetime is made possible by using proven hard sealed HeNe laser technology. Over twenty years of experience and multiple process improvements are incorporated into every laser tube manufactured for Lighthouse products. The purpose of this document is to provide additional information about the life span of the HeNe laser tube inside the SOLAIR 1100+.
Multi-point Monitoring in Minienvironments
Minienvironments and isolation technology have become commonplace in semiconductor and other high technology manufacturing industries. The use of minienvironments and the associated automation allows for greater levels of control as well as improved process cleanliness.
Multi-point Sampling for AMC Monitoring
Monitoring for any type of contamination is an important aspect of contamination control. Monitoring specifically for AMC is important in industries where AMC can directly affect the product or process. Airborne Molecular Contamination (AMC) is chemical contamination in the form of vapors or aerosols that have a detrimental effect on a product or a process. These chemicals may be organic or inorganic in nature and include acids, bases, polymer additives, organometallic compounds and dopants. The main sources of AMC are building and cleanroom construction materials, general environment, process chemicals and operating personnel.
Particle Monitoring in Pharmaceutical Cleanrooms
Environmental monitoring is an important aspect of regulatory and quality control in the production of pharmaceuticals. The manufacturing environment must be controlled and monitored during the production of drugs. Final drug products must be sterile and free from contamination. Terminal sterilization and aseptic processing are the two paths taken to produce sterile drugs. Terminal sterilization is the process of sterilizing materials and containers, done with the material in its containers, with the product in its final form.
Particle Transport in Tubing
Airborne Particle Counters (APC) are used for a variety of purposes such as: • Filter testing • Cleanroom certification and testing • Isolator and minienvironment testing and certification. Often the use of APCs requires the use of tubing for the sampling of the air as the APC may be located some distance from the actual air being sampled. Various factors impact the efficiency of particle transport in tubing. Factors such as sample air velocity, tubing length, tubing material, the number of bends, radius of such bends and tubing diameter need to be considered in selecting and using such tubing.
Real Time Process Monitoring
A common approach to controlling contamination in high technology manufacturing cleanrooms is the continuous monitoring of particles. Either dedicated, discrete, “real-time” particle counters or a multi-port pneumatic manifold system to sample multiple locations throughout the cleanroom can be used to accomplish this goal.
Maintaining Validation and Calibration
A wide variety of scientific instruments are used on a regular basis to assist in our daily IAQ investigations. Moisture meters, temperature and relative humidity probes, infrared cameras, and particle counters all have a couple of things in common. First, they are invaluable assets for successful completion of our day-to-day jobs. Second, they all are finely tuned instruments that require scheduled maintenance and calibration.
What do Particle Counts Mean?
When using particle counters, one needs to be aware of certain terms or phrases that are commonly used when describing functions of the instrument, or how the data is viewed and reported. Data are displayed in either Cumulative or Differential mode. When viewing the data in Cumulative mode, the number (counts) associated with each channel size is the number of particles that the instrument counted for that size and greater.
Indoor Air Quality Monitoring – Aerosol Particle Counter used in Mold Investigation at Local School
Poor indoor air quality in our educational facilities is an ongoing concern in many communities. Mold in particular, has teachers, students, parents, and administrators across the country looking very closely at possible causes of contamination, and the associated costs of dealing with these problems. A growing number of professionals conducting IAQ investigations are utilizing a wide variety of testing instrumentation, including aerosol particle counters, to aid in better defining these contamination sources. I recently spent time assisting with an IAQ investigation at a middle school (Grades 6-8) in Southern Oregon, and will share the testing methodology and results in this article.
Manufacture of Sterile Medicinal Products
The manufacture of sterile products is subject to special requirements in order to minimize risks of microbiological contamination, and of particulate and pyrogen contamination. Much depends on the skill, training and attitudes of the personnel involved. Quality Assurance is particularly important, and this type of manufacture must strictly follow carefully established and validated methods of preparation and procedure. Sole reliance for sterility or other quality aspects must not be placed on any terminal process or finished product test.
EU GMP Annex 1 Update 2008: Airborne Particle Counting
Morgan Polen – VP of Applications Technology, Lighthouse Worldwide Solutions. On February 14th, 2008, The European Commission updated Volume 4 EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Annex 1: Manufacture of Sterile Medicinal Products. This update comes into operation on March 1st, 2009. (With the provisions on capping of freeze – dried vials implemented by March 1st, 2010).
Particle Sample Tube Lengths For Pharmaceutical Monitoring
Morgan Polen – VP of Applications Technology, Lighthouse Worldwide Solutions. Airborne Particle Counters (APC) are used for a variety of purposes in pharmaceutical cleanrooms for such applications: Filter testing, Cleanroom certification and testing, Isolator certification and testing, Cleanroom and clean device monitoring in Pharmaceutical Manufacturing Facilities.
Point of Use Particle Counting In High Purity Applications
DI water is used extensively in electronics manufacturing. In semiconductor manufacturing it is used for cleaning and etching wafers. DI water is also used in CMP processes and the critical immersion lithography process. Up to 1000 gallons of water is needed to process a single 300mm wafer. Because DI water is used in many critical process steps and directly contacts the wafer, controlling its contaminants is critical to maintaining high yields. On line monitoring of particle levels is a common method of controlling contamination in DI water systems.
Meeting the ITRS Roadmap Guidelines for Particle Measurements in Ultrapure Water
DI water is used throughout electronics manufacturing. In semiconductor manufacturing it is used for multiple processes including the cleaning and etching of wafers. DI water is also used in other critical semiconductor processes such as CMP and immersion lithography. Over one thousand gallons of water is needed to process a single 300mm wafer. Because DI water is used pervasively and because it directly contacts the wafer, controlling its contaminants is critical to maintaining high yields in the semiconductor industry. On line monitoring of particle levels is a standard method of controlling contamination in DI water systems.
Risk Based Approach to Particle Monitoring
Airborne particle counters are an important tool used in the environmental monitoring of pharmaceutical, bio-pharmaceutical and healthcare facilities worldwide. In addition to determining air quality as part of the facility qualification, particle counters are required tools used in confirming air cleanliness in critical areas where high-risk operations are carried out. Non-viable particle counters and their associated systems are part of a larger environmental monitoring program that includes;
- Non-viable particle monitoring of air
- Viable particle monitoring of air, surfaces and personnel
- Pressure differential monitoring
- Temperature and relative humidity monitoring