Keep in Mind Series No#5
Cleanroom Classification Tables "All-in-One"
GMP Annex 1 current version (2008) and ISO 14644 Part 1 2015 revision have tables to define particle limits for Classes (ISO) and Grades (GMP) for considered particle size. ISO also defines sample locations based on the cleanroom area and GMP also applies the same Table A1 to define a number of locations. Print this table and keep it as...
Kap Kapak Bütünlüğü ve Derin Dondurucuda Saklama
Pharmaceutical Technology E-kitap
China International Pharmaceutical Machinery Expo
CIPM was held in Wuhan on November 3-5, 2020 There was an estimated 1300+ exhibitors who participated with a record total of 80k visitors. Distributor, North River led by Mr. Shen JunQiao participated with various Lighthouse products such as the Apex Z-series and AC100H!READ MORE
Successful Training Days!
Thanks to the simplified Light-scattering airborne-particle counter (LSAPC) method in ISO 14644-3 test method standard 2019 revision, ScanAir Pro is now more attractive than ever before for validation and qualification professionals. Lighthouse EMEA organized training days for 'Cleanroom Standards' and LSAPC method for filter testing with ScanAir Pro for its new Scanair customers. The Lighthouse team measured the effectiveness of the training with...READ MORE
Keep in Mind Series No#3
How to Test HEPA Filter Integrity?
How to Test HEPA Filter Integrity? ☑ Measure the aerosol concentration upstream of the filters ☑This aerosol concentration should be used as the upstream 100 % reference for the photometer. Downstream measurements are then displayed as percentage penetration of upstream concentration ☑The probe should then be traversed at a scan rate...
Keep in Mind Series No#4
Good Sampling Practice : Particle Counter Sampling Tube
Good Sampling Practice: Particle Counter Sampling Tube Always mount your isokinetic probe directly to your particle counter and use trolley/SSL CART for sampling in a room. Particle Counters always come with a 3-meter sampling tube. Cut the tube with the shortest possible length, not more than 1 meter. Never use the entire...
How do particle counters work?
Understanding how particle counters work is crucial to making informed decisions in the operation of a cleanroom. Jason Kelly, director of systems, Lighthouse Worldwide Solutions, explains the technology and stresses the importance of data integrity in Cleanroom Technology magazine. Click for the article!
Keep in Mind Series No#2
Cleanroom Classification vs Minimum Sample Duration
Table showing minimum duration (minutes) if you are using 1 CFM (28.3LPM) Particle Counters. According to ISO 14644-1:2015; If concentrations are leading to large air sample volumes for classification, a sequential sampling procedure may be applied. You can find it in Annex D. The volume sampled at each location shall be at least 2...
Keep in Mind Series No #1
According to ISO 14644-1:2015 cleanroom classification standard, Required Single Sample Volume (VS) is the only formula (Formula A.2) that you should calculate as; Vs=(20/Cn)*1000 Where, Cn is the class limit for the largest considered particle size. If you print the below table out, you don’t have to calculate every single...
New Faculty of IEST ISO 14644 Fundamentals Training!
New ISO 14644-3:2019 - Basic Information and Implementation
Hasim Solmaz, General Manager of Lighthouse EMEA Operations received an invitation to join The Institute of Environmental Sciences and Technology Contamination Control Institute (IEST CCI) as a faculty. As a secretariat of ISO TC209, IEST is the leading technical, nonprofit membership association that connects professionals who are...
ISO 14644-3 Filter testing with Light-scattering airborne-particle counter (LSAPC) method
Thanks to the simplified Light-scattering airborne-particle counter (LSAPC) method in ISO 14644-3 test method standard 2019 revision, ScanAir Pro is now more attractive than ever before for validation and qualification professionals. Lighthouse EMEA organized training days for the 'Cleanroom Standards' and LSAPC method for...
New ISPE Guideline is published with Lighthouse's contribution as an author!
Good Practice Guide: HVAC & Process Equipment Air Filters
In the pharmaceutical industry, the correct specification and application of air filters in HVAC systems and certain process equipment are critical to maintaining the environment at appropriate cleanliness. The Guide was written by leading experts in the pharmaceutical industry on the subject of HVAC and air filters, making it a...
A Budding Market
Lighthouse Worldwide Solutions is featured on the cover of the current edition of Cleanroom Technology, as well as in a corresponding advertorial!
Congratulations to Lighthouse Worldwide Solutions for another front cover feature on Cleanroom Technology's March 2020 edition! Lighthouse paperless clean room solutions can eliminate most of the manual and time-consuming tasks associated with sampling, data collection, excursion management and data consolidation. If you would like to learn even more, please sign up for our Upcoming Webinar: Particle Monitoring - Going Paperless in the...READ MORE
Lighthouse is Partnering with KENX for the "Cleanroom Validation, Disinfection, & Environmental Monitoring" Conference, February 17th - 19th in San Diego
At 12pm Wednesday, February 19th, Jason Kelly, Vice President of Services, Lighthouse Worldwide Solutions will be presenting on the topic of "Environmental Monitoring System Design – to meet cGMP"
SESSION DESCRIPTION With the never ending shift towards continuous quality improvements within the manufacturing of pharmaceutical products it is worth looking at the current requirement of GMP and also 21CFR11 in the context of GAMP 5 requirements. How a Company creates, maintains, retrieves, corrects and controls data can affect...
Turkish Cleanroom Day!
As a member of International Confederation of Contamination Control Societies (ICCCS); Cleanroom Technologies Society of Turkey (CTS) celebrated 4rd anniversary with “Turkish Cleanroom Day” event. As founding chair, The keynote address was given by Lighthouse EMEA GM Haşim Solmaz. The Turkish Cleanroom Day event which is planned to be held on the same day every year, was held with 270 participants from different companies.READ MORE
Sales & Service Training
From October 15th-17th, the Lighthouse EMEA conducted the Sales and Service training regarding Apex Z, AC100H and ScanAir Pro Training. There were distributor participants from Greece, Metrolab and Ukraine, Technoprolab. It was a jammed pack and successful 3day event for everyone!
MS Pharma Turkey has chosen Lighthouse quality!
Lighthouse online monitoring system installation&validation service
MS Pharma is a pharmaceutical company located in Jordan that manufactures and markets branded and generic medicines throughout the META region. The Lighthouse EMEA team completed the MS Pharma online monitoring system installation and system validation service in ampoule filling, parenteral filling and vial filling lines designed in...
Lighthouse EMEA BioExpo
Lighthouse EMEA Bioexpo Exhibition After Movie!
The BioExpo 2019 Exhibition which took place in Lütfi Kırdar Congress Center in Istanbul from 17 to 19 April 2019, hosted participants and visitors from many different sectors from Cleanroom Technologies, Biotechnology, Pharmaceutical Industry, Analysis, and Laboratories. Lighthouse EMEA was the International Communication Sponsor...
Discrete Particle Counter Method for Filter Testing
General Filter Havak is one of the largest filter manufacturing companies in Turkey since 2008 providing air filter production, sales, import and export services. One of our on-site training was organized for Havak this week. They use ScanAir Pro System which is filter testing system for HEPA and ULPA filters, according to the ISO 14644-3 Test Methods standard DPC (Discrete Particle Counter) method. ScanAir Pro System is preferred by filter manufacturers on their...READ MORE