OSHA Respirable Crystalline Silica Rule- Mesa Labs

The new OSHA Respirable Crystalline Silica Rule was published in March of 2016. All industries have responded which raised various questions regarding the new rule. Industry leaders want to know how they will be affected and why the new rule was written.

 

Mesa Labs wants to simplify the compliance process for its customers and thus has defined main points of the rule in an easy-to-follow manner.

  • Respirable Crystalline Silica is one of the most abundant materials in the Earth’s crust. It exists in three distinct forms: quartz, cristobalite, and tridymite. It occurs in the workplace when workers cut, grind, drill, saw, crush or process materials such as rock, sand, glass, stone, or brick. It can also be a byproduct of sandblasting, and hydraulic fracturing.
  • This rule is necessary because robust evidence indicates that current exposure limits do not protect workers’ health. Also, OSHA believes the new standards will prevent 642 deaths per year, which is projected to save employers $7.6 billion per year, based on the reduced mortality rates.
  • The new rule differs in three primary ways:
    • The new Permissible Exposure Limit (PEL) is 50µg/m3 per eight-hour Time Weighted Average (TWA) and employers must measure worker exposure if levels reach or exceed 25 µg/m3 as an eight-hour TWA.
    • Employers will implement techniques to greatly reduce workers’ exposure, such as wetting down or vacuuming dust to prevent workers from breathing it in.
    • Employers are also required to identify high-exposure areas and limit access to those areas. They are also required to offer respiratory protection plans, and possibly medical exams.

The new rule is set to a timeline, determined by OSHA.

  • June 23, 2017 – the construction industry must comply
  • June 23, 2018 – general and maritime industries must comply
  • June 23, 2018 – the hydraulic fracturing industry must comply

 

Source: http://mesalabs.com/2017/07/05/osha-respirable-crystalline-silica-rule/

Happy Independence Day !!!

              The Life Scientific Inc  ( LSI ) team would like to wish our valued customers a happy 4th of July.

 

Mesa Labs Compliance and Validation Services Now Offered Through Life Scientific, Inc.

For Immediate Release

 

Mesa Labs Compliance and Validation Services Now Offered Through Life Scientific, Inc.

St. Louis, MO January 3, 2016- Life Scientific, Inc. will now represent Mesa Laboratories’ Validation Services with the new agreement signed by both companies December 2016. The agreement allows Life Scientific, Inc. to represent and help grow Mesa’s Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols and services.

Mesa’s Validation Team has 14 years of experience providing IQ, OQ, PQ Qualifications and Temperature Mapping to Incubators, Freezers, Refrigerators, Autoclaves, Depyrogenation Ovens, and Lyophilizers; Cleanroom Qualifications via in-house Certified Microbiologist (RM/NRCM), including viable and non-viable monitoring for routine monitoring and also to determine the placement of the non-viable particulate measuring equipment to meet ISO, FDA, 503b and EU requirements; and our final report packages are designed to meet your cGMP/GDP/GLP requirements. NIST Traceable calibrations are performed in-house via Mesa’s ISO 17025 accredited calibration laboratory. Mesa also gives Equipment Qualification & Calibration to reactors, mixing vessels, homegenizers, fluid beds, filter dryers, etc. Mesa’s superior knowledge and experience in validation, calibration and compliance make them a trusted source for verifying your equipment is ready to use.

Since 1992, Life Scientific has consulted on more than 5,000 equipment opportunities with industry leading clients in Pharmaceutical, Biotech, Medical Device and Industrial markets.  Life Scientific has also been representing Mesa’s CAP Testing Torque Division since 2014 and has since then become an expert on Torque equipment assisting several customers with their cap testing needs. Representatives all have engineering, project management, and technical backgrounds to help facilitate your projects from start to finish. Let us help you gain compliance and reduce risk for your operations!

 

http://validation.mesalabs.com/

Trusted by the world’s leading brands …

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Come See Us at the Pack Expo International and Pharma Expo!

The world’s biggest packaging and processing conference and trade show with over 2,000 exhibitors showcasing their most advanced machinery!

Follow here to learn more: http://pharmaexpo.com/

Come see Life Scientific Inc. staff and the manufacturers they represent November 6th-9th. To set up a meeting, call one of your representatives:

  • Mike Bellm (314)941-9000
  • MaryBeth Eyer (217)825-8110
  • Ben Krech (312)545-2164

Bahnson Environmental Specialties (Pharma Expo) West Building Booth W-956
Bahnson Environmental Specialties (BES), an EMCOR Company, is a leading Controlled Environmental Chamber Manufacturer that provides design, installation, service, & validation of standard or custom-built Walk-In Controlled Environmental Chambers for close tolerance temps/RH mainly to the pharmaceutical & research markets.
Bonfiglioli Engineering (Pack Expo) South Hall Booth S-1538
Bonfiglioli Engineering sales staff will be available to answer any question regarding Bonfiglioli Engineering technologies and solutions as non destructive Leak Detection, Visual Inspection and Headspace Gas Analysis for Laboratory and in-line container intergrity testing.
Cozzoli Machine Company (Pack Expo) South Hall S-2142
Cozzoli Machine Company will be exhibiting their latest filling and closing technology. Featured machines includes the FSV50 Mini Monoblock, the FPS2-SS Ampule Filling & Sealing Machine, and the Versa Fil Time Pressure Filler. They will also show some tabletop equipment including our F400X Single Piston Liquid filler and the PF2IS powder filler, confirgured for use in an isolator.
Mesa Laboratories (Pack Expo) East Hall Booth E-10632
Mesa Labs is the world’s leading cap torque testers for every type of bottle. Please stop by their booth If you are interested in a live demo of the latest in cap torque technology, or a free consultation!
Newman Labeling Systems (Pack Expo) South Hall Booth S-4382
Newman Labelling Systems, a leading supplier of specialist pharmaceutical labelling systems, will be demonstrating its CTE350 automatic labeller and will preview a new Print & Apply labeller.

2016EQUALPack_Pharma_logo_revised_ISPE_4c

1st PDA Europe Annual Meeting

Berlin, Germany, June 28-29, 2016, Booth 17

The latest trends in injectable products, manufacturing technologies, and testing methods, and the respective regulatory developments  will be the main focus of the upcoming PDA 1st PDA Europe Annual Meeting that will take place in the beautiful location of Estrel Berlin hotel in Berlinfrom June 28th to June 29th, 2016.

Testing, Process Control and Monitoring session will cover the following interest points:
–  Modern Analytical Techniques Overview
–  Techniques in Head-Space Analysis
–  Rapid methods
–  Online methods
–  What data are meaningful in assessing quality

During the event are planned interesting presentations and discussions with experts: Bonfiglioli Engineeringintervention will be given by Mr. Andrea Simonetti (Director of Pharma) presenting on Tuesday, 28th June 2016 at 15:05 during the “Session 1B: Testing”: “All-in-One Solution for Parenteral Containers CCI Testing and Headspace Gas Verification “.

Testing methods for CCI verification throughout drug product lifecycle can be discussed by Bonfiglioli Engineering tabletop # 17. Bonfiglioli Engineering staff will be available to answer any question regarding Bonfiglioli Engineering  technologies and solutions as non destructive LeakDetection, Visual Inspection and Headspace Gas Analysisfor Laboratory and in-line container integrity testing.
The complete and detailed agenda and information of the event can be consulted at PDA website under 1st PDA Europe Annual Meeting event: https://www.pda.org/global-event-calendar/event-detail/1st-pda-europe-annual-meeting

See More At: http://www.bonfiglioliengineering.com/news-events/491/1st-pda-europe-annual-meeting.html

JVNW Builds Its Largest Automated Brewhouse For Isle Brewers Guild

Canby, Ore. — Manufacturers of custom brewing systems, JVNW announced that they are completing a state-of-the-art 100 BBL 4-vessel automated brewing system that will soon travel the length of the country to find its home at the Isle Brewers Guild (IBG) in Pawtucket, RI. The brewhouse is PLC controlled including a fully sequenced CIP system and is the largest undertaking for the company who manufactures 100% of their equipment in Oregon.

The system will certainly be put to the test as it produces an assortment of beer styles from established mid to large-size craft breweries looking to expand their capacity, sales and distribution. Isle Brewers Guild is a Partner Brewery, where brewers will brew their beer under the care and supervision of their own brewmaster. IBG co-founder, Devin Kelly, emphasizes “our goal is to provide for our partner brewers an efficient brewing solution with better control and customer service. JVNW has been a great partner throughout the planning process, and we are thrilled to be working with a US company with a long history of brewing.” Due to the high volume required of the JVNW brewing system, along with the numerous brewing techniques that will be required, the brewhouse features a number of custom designs. “This equipment was made to very exact specifications from IBG and will serve the Pawtucket brewing community well” says Jared McClintock of JVNW with a smile on his face, “we had a lot of fun making this system for them.”

Due to increasing demand within the craft segment, the need for additional capacity remains a fundamental issue for craft brewers. The JVNW brewhouse will provide brewers with all the flexibility of their own brewery without the capital exposure. The IBG Venture goes beyond brewing and will provide:

  • Over 4,000 sq. ft. retail operation with tasting room and function facility
  • Educational courses in brewing and fermentation science
  • Wide range of raw material and ingredient options
  • A wide range of packaging options including high speed can and keg lines

About JVNW, Inc.:

JVNW, Inc. is a manufacturer of custom beer tanks and craft brewing systems in Canby, OR. Founded in 1981, JVNW is proud to be one of the early pioneers of today’s successful Craft Brewing Industry. The country’s first legal turn-key brewpub was designed and built by JVNW way back in 1983 right outside the University of California gates in Berkeley. Triple Rock has expanded over the years but still runs profitably on its original brewhouse.

http://jvnw.com

http://www.islebrewers.com

PHARMACEUTICAL AND BIOTECHNOLOGY DEVELOPMENT AND MANUFACTURING INNOVATION THRIVES AT INTERPHEX 2016

NEW YORK, NY – May 5, 2016 – International Pharmaceutical Expo (INTERPHEX), the premier event dedicated to pharmaceutical and biotechnology innovation, technology and knowledge from development through commercialization, sponsored by the Parenteral Drug Association (PDA) , today announced an +18% increase in Pharmaceutical Engineers and a +4.5% increase in total attendance for its 2016 event. Attendees and exhibitors from 48 states and 52 countries joined together at INTERPHEX 2016 to experience the latest in technology, and leading edge education. An exhibit hall featuring more than 600 leading suppliers was supported by a new cutting-edge technical conference, the inaugural two-day Keynote Series with Pharmaceutical Technology, Poster Hall and Awards with BioProcess International and INTERPHEX Live with Pharmaceutical Processing . INTERPHEX 2016 was held April 26-28 at the Jacob K. Javits Center in New York City.
“INTERPHEX 2016 was a resounding success for both exhibitors and attendees alike who hailed from 52 countries around the world and 48 states across the U.S.,” said Ed Several, Senior Vice President, INTERPHEX. “This year’s INTERPHEX once again succeeded in bringing together inspired professionals with key industry leaders to share knowledge and best practices, as well as see the latest cutting-edge technologies needed to cost-effectively develop and manufacture quality products.”
INTERPHEX 2016 debuted a new two-day Keynote Series that featured industry experts delivering insights on key themes including drug shortage, continuous manufacturing, overcoming bottlenecks, technology advances in solid dosage, sterile manufacturing challenges, and the contract services market.
During the Keynote Series, Dr. Stephen Spielberg led an engaging presentation titled, “An Interdisciplinary Approach to Address Drug Shortages” that explored alternative, innovative and cost-effective methods to provide needed therapies to patients. “One of the biggest threats to public health in the U.S. is drug shortages and, in order to solve this growing problem, we have to approach manufacturing in a very different way,” said Dr. Stephen Spielberg, CEO and President of the Secure Affordable Quality Supply (SAQS) Alliance , a non-profit focused on drug shortages and future of the pharmaceutical manufacturing. “Through a public and private partnership, we can create a financially viable, hybrid manufacturing operation where we can ensure quality, consistent drug production and keep costs down. Technology is a major component to making this happen, and that is why INTERPHEX is such an important event – it’s where pharmaceutical science and commercialization merge.”
“It was a pleasure being at INTERPHEX and participating. The show and the sessions were a blast. In my amazement, at the session, all the chairs were filled and many were standing in the back and on the sides”, said Robert Dream, Managing Director, HDR Company LLC. “Many attendees stayed afterwards and asked many questions. INTERPHEX has improved on quality and accessibility for attendees on all fronts and I am glad to be a part of it.”
“We see INTERPHEX as a key platform to connect with the market, and gauge the pulse of the industry. Undeniably, continuous processing was the talk of the show, and at Pall Life Sciences , we have developed several technologies designed to enable continuous processing in key downstream unit operations,” said Michael Egholm, PhD, VP & General Manager of Biopharmaceuticals. “It is extremely valuable to hear the input from customers as we continue to develop this industry leading platform, and create new solutions to continuously improve bioprocessing for the industry. Our team looks forward to sharing our advances in continuous bioprocessing in 2017.”

INTERPHEX has transformed into the industry event where more and more manufacturers are launching cutting-edge technologies, products and value-added services for worldwide development and manufacturing operations, including Marchesini Group, MG America, Pall Life Sciences, SKAN, BOSCH, CVC Technologies, Fette Compacting, Watson-Marlow, Entegris, NJM Packaging, PendoTECH, Whitehouse Laboratories, and more.
“We are extremely satisfied with the attendance and quality of our leads”, said Dan Lapierre, Vice President, NJM Packaging. “We met many new customers and reconnected with our current customers. We look forward to next year.”

The following are key highlights from INTERPHEX 2016:

The second inaugural, three-day INTERPHEX Live enabled industry professionals to gain valuable insights on a variety of topics such as continuous processing, augmented/virtual reality, biosimilars, overcoming facility upgrades and more. Both attendees and exhibitors had the opportunity to view presentations and panels live on the show floor studio, broadcast throughout the show floor and “on-demand” viewing post-show on the INTERPHEX and Pharmaceutical Processing websites.

Back by popular demand, SKAN US, Inc., a subsidiary of SKAN AG Switzerland and the world’s largest provider of isolator technology, once again held the SKAN Engineering Olympics at its booth. The contest showcased the dexterity and flexibility of its PSI-L Flange Isolator while allowing attendees to compete for prizes.

DME , a provider of a wide array of engineering solutions, featured the new DME Facility Focus, encompassing feedback and analysis regarding Biopharmaceutical Facility Modernization and Aseptic Manufacturing Technology Trends. “INTERPHEX has become an indispensable vehicle to reach our market and meet with key clients”, said Dave Marks, P.E. and President of DME. “We were extremely pleased to launch the DME Facility Focus educational program at INTERPHEX, which provided an excellent opportunity to showcase DME’s thought leadership and enhanced the overall experience of attendees at the event.”

INTERPHEX 2016 Exhibitor Awards
In conjunction with Pharmaceutical Processing, INTERPHEX announced the winners of its Exhibitor Awards which recognized innovative technologies and/or new strategies and services that have significantly contributed to the industry.

Best in Show: GE Healthcare Life Sciences

GE Healthcare Life Sciences was recognized for KUBio™ , a prefabricated cGMP-compliant facility and process solution designed for the scalable and cost-efficient production of monoclonal antibodies (mAbs). “INTERPHEX provided us an opportunity to showcase our complete manufacturing solution, KUBio™, and help attendees experience this flexible, turnkey modular facility and understand why it is resonating strongly with our customers,” said Parrish Galliher, Chief Technology Officer, Upstream, GE Healthcare Life Sciences.

Efficiency Champion: Millipore Sigma

Millipore Sigma was recognized for Mobius® 1000 L Single-Use Bioreactor , a stirred tank bioreactor that configures software, hardware, and single-use assemblies for use in suspension and adherent cell culture applications. “INTERPHEX is THE trade show for our hardware and single-use business,” said Oliver Klaeffling, Vice President, Head of Upstream & Systems, MilliporeSigma. “This is the year where we’ve launched the most products ever. We have the new 1,000-liter Bioreactor, the new Power MIX, and the revolutionary product in terms of sterile connecting and reconnecting, the Lynx CDR, which is going to change the industry. I’m very happy we won the Efficiency Champion award for our new bioreactor. It’s exactly what the product was designed for-ease of use and increasing manufacturing efficiency for our customers. I’d like to thank our R&D and marketing teams for their hard work on this.”

Best New Product/Service: Nemera

Nemera was recognized for Novelia® BFS , a preservative-free multi-dose eyedropper combined with bottlepack® technology. Novelia® works with high viscosity suspensions and solutions of up to 1500 cps and limits the distribution of liquids to one drop at a time. “INTERPHEX was a great opportunity for us to have high-quality discussions and meet several customers and prospects,” said Patrice Lewko, Vice-President Marketing and Innovation, Nemera. “We are proud to have Novelia® awarded as ‘Best New Product’ at INTERPHEX 2016. With Novelia®, Nemera is proud to bring a safe and cost-effective solution for eliminating preservatives from eye drops. This is improving treatment compliance and patients’ safety and comfort. By combining Novelia® with the Bottlepack® blow-fill-seal technology by Rommelag, we make it even safer, more convenient and easier to implement.”

Other INTERPHEX 2016 award winners include:

Biotech Innovation Award: Bausch + Stroebel for VarioSys®, a flexible processing line based on the lock-and-key principle.

Best Technological Innovation: Videojet Technologies for its Videojet® 7510 50-Watt Fiber Laser Marker , a laser marking system with high contrast marking on robust plastic packaging, metal containers, as well as other industrial products.

Editor’s Choice: Catalent Pharma Solutions for its OptiForm® Solution Suite , a detailed molecule assessment with high throughput screening and parallel assessment of formulation technologies.

Join Pfizer, AbbVie, Lilly, Sanofi, and many more in Philadelphia!

2016 Pre-Filled Syringes Forum, April 4-5 Philadelphia, PA

Strategic Development, Safety & Regulatory Compliance, and Commercialization of Pre-Filled Syringes

Pharma Ed Resources, an industry leader since 2004 in delivering market-driven research on pre-filled syringes, is proud to announce its 2016 Pre-Filled Syringes Forum. With the global market for PFS expected to top $6.5 billion dollars by 2020, the biopharmaceutical industry is looking for next generation materials, technologies and production strategies to streamline commercialization and to adapt quickly to a changing regulatory environment. That is why you cannot afford to miss this intensive two-day training event. Pharma Ed brings together top researchers and innovators to share best practices and the latest science, enabling you to maximize your organization’s leverage in this dynamic and growing market.

Featuring Representation From:

  • Pfizer
  • AbbVie
  • Lilly
  • Sanofi Pasteur
  • BioNTech
  • Terumo
  • Bosch Inspection
  • Ypsomed AG
  • West
  • Zeon Chemicals
  • Datwyler
  • ICP Consulting
  • Daikyo Crystal Zenith
  • Material Needs Consulting
  • Eakins & Associates
  • Schott Pharmaceutical Packaging
  • RapID

To Register go to  http://www.pharmaedresources.com/registration.cfm