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Lighthouse provides complete validation services for your system.
- System Design
- User Requirement Specification
- Design Qualification
- Installation Qualification
- Operational Qualification
- Installation
- Factory Acceptance Testing
- Site Acceptance Training (IQ/OQ)
- Training
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| TECHNICAL DOCUMENTS |
Particle Sample Tube Lengths For Pharmaceutical Monitoring  Download PDF File |
| 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 |
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| EU GMP Annex 1 Update 2008: Airborne Particle Counting Download PDF File |
| 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). |
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| Particle Monitoring in Pharmaceutical Cleanrooms Download PDF File |
| 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. |
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| Facility Monitoring Systems and 21 CFR Part 11 Compliance Download PDF File |
| The United States Food and Drug Administration (FDA) is the government agency responsible for the approval of new drugs and the controls for manufacturing of pharmaceuticals consumed in the United States. All drugs manufactured in the United States and all drugs imported to the U.S. are subject to FDA regulations. Different national regulations are similar to the FDA regulations in purpose but the importance of the U.S. market is such that the FDA regulations are given prominence. |
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| How to Select a Particle Counter for my Cleanroom Download PDF File |
| 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. |
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| Cleanroom Requirements, Certification and Monitoring Per Common Accepted Standards Download PDF File |
| 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. |
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| Real Time Process Monitoring Download PDF File |
| A common approach to controlling contamination in high technology manufacturing cleanroom 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. |
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| Continuous Particle Monitoring Download PDF File |
| 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. |
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