Regulatory Accreditation for Pharmacies by Mesa Labs

Recent changes in regulatory guidance towards temperature control has placed more emphasis on storage, packaging, shipping, & monitoring of the products you use. And, pharmacists have a responsibility to store temperature sensitive medicines and vaccines appropriately.

Correct refrigeration of temperature sensitive medicines is a vitally important yet often overlooked issue. All too often, domestic fridges are used for medical use, and these appliances do not provide high enough safety standards for the storage of pharmaceutical products. In addition, vaccines and other refrigerated medicines must be transported in an appropriate manner which ensures the correct temperature range is maintained.

The outcome may be that the patient is not protected by the vaccine and it can result in costly wastage of vaccines or even worse, lives.

 

Mesa Labs regulatory compliance services can address the full range of regulatory and accreditation requirements with which your hospital must comply. From a Regulatory Gap Analysis, the purpose of which is to document the regulations and guidelines with which you must comply, including the identification of any existing deficiencies, to the development of a Validation Master Plan and the following execution, including staff training, the Mesa Labs team can work with you to ensure full compliance.

The overall regulatory areas in which the Mesa Labs team can assist you include:

  • Regulatory GAP Analysis
  • Validation Master Plans
  • Remediation Plans
  • Validation services, including – Process, Systems and Equipment
  • CAPA Programs
  • Risk Analysis
  • Review and Development of Standard Operating Procedures (SOPs)
  • Remote temperature monitoring
  • Staff training
  • Quality Management Systems
  • Document Control Processes
  • Corrective and Preventative Actions and Processes
  • Internal Audits
  • Operational Standards, including purchasing, inventory management, results reporting and many others
  • Specimen Collection, storage and processing standards

 

 

 

 

 

 

 

 

Source: https://temptrust.mesalabs.com/packaging-services/pharmacy-regulatory-services/

THE UNIVERSE OF PRE-FILLED SYRINGES AND INJECTION DEVICES

 

TASITEST Packaging Test and Inspection, The Parent group of Bonfilioli Engineering is delighted to announce its participation at 14th edition of PDA The Universe of Pre-filled Syringes and Injection Devices at the beautiful location of Austria Center Vienna from 7th to 8th November 2017.

developments, regulatory considerations, trends and best practices in the field of parenteral drugs. TASITEST intervention is scheduled on Wednesday, 8 November at 9,30 am at Hall G in the TRACK B Manufacturing and Technology and it will be given by Mr. Giovanni Golinelli, our Product & Application Specialist, presenting Finished Pre-filled Syringes Integrity Testing: Method Development, Validation and 100% in-line High Speed Solutions.

During the 2 days event, TASITEST will welcome you at tabletop # X 91 where the LF-S 11 application will be showcased and you can discover the latest innovations in non destructive, non invasive Container Closure Integrity Testing, Visual Inspection and Headspace Gas Analysis for Laboratory and In-line packaging markets solutions.

Our Area Sales Managers, Mrs. Serena Santi and Mr. John Park will take part in the event and will be more than happy to show TASITEST range of products and technologies applicable to the Pharmaceutical packaging (and specifically to the Prefilled Syringes) representing the perfect combination of product stability, testing efficiency and maintenance simplicity.

The complete and detailed agenda of the event can be consulted at PDA website, www.pda.org/conference/the-universe-of-pre-filled-syringes/home

Our New Manufacturer VetroMeccanica

 

 

 

 

 

We are proud to announce that we now represent VetroMeccanica throughout the Midwest. They design / build conveyance systems for primary and secondary packaging. Vetromeccaninca is a global producer with sales, service and parts distribution offices in the US, and installations in over 70 countries. http://www.vetromeccanica.net/about-us

 

Vetromecanica specializes in tailor made and highly customized:

Bulk Conveyors
Air Conveyors
Table-Top Conveyors
Multipack Conveyors
Elevators / Lowerators
Dividers
Air Tunnels
Special Custom Conveyors

They are famous for their Automatic Line Control Geo-synch “Synchro” Systems. It’s mostly suitable to eliminate product gaps by controlling carefully container flow before entering decapper, rinser, filler or labeler. The customers profit can be measured in terms of space and energy costs when deciding to include Vetro’s Syncro system in their Semi and Fully Automated Production Lines.

We are currently scheduling Mid-November client meetings with our VetroMeccanica Project Specialist.

Contact us if you are interested in learning more about how we can help facilitate any jobs you may be considering.

 

Modular Walk-In by Bahnson

Bahnson Environmental Specialties (BES) designs and manufactures a diverse product line of controlled environmental chambers / rooms throughout a wide variety of industries. Standard and custom environmental chambers / rooms include:

  • Walk-in temperature and humidity chambers
  • Walk-in warm rooms
  • Walk-in cold rooms
  • Walk-in freezers
  • Walk-in incubators
  • ICH stability chambers
  • Shelf life study chambers
  • HEPA filtered clean cold rooms
  • HEPA filtered clean warm rooms
  • Test chambers
  • Plant growth chambers
  • Shelf lighted rooms
  • 1% and 2% dry rooms
  • Other low humidity dry rooms

These are just a sampling of room types included in our walk-in environmental chamber series.

In the pharmaceutical market, our focus on stability rooms meeting and exceeding the ranges and uniformities of the ICH has allowed us to become the recognized leader in chamber design, construction, and stringent performance qualification in support of our clients’ validation.

We also supply universities, medical schools, and industrial customers with chambers requiring uniform dependable room conditions for storage and testing experiments.

Our resume includes some of the largest installations of multiple environmental rooms in notable research buildings on campuses throughout the US.

If you have any question, feel free to contact Julie Durnbaugh, jdurnbaugh@bahnson.com, 919-829-6074.

Introducing Bonfig’s Lasercube

We recently introduced the BONFIG LASERCUBE to the US market, a bench top system for performing Headspace Gas Analysis (HGA) analysis for a variety of containers. It’s debut was at this year’s Pack Expo Las Vegas.
LASERCUBE provides a non-destructive, non-invasive laser-based inspection solution for leak detection and container closure integrity testing (CCIT) by measuring the headspace level of gases, such as oxygen and carbon dioxide, as well as monitoring moisture levels.

HGA is suited for accurate investigation of translucent containers and pharmaceutical finished containers, as well as headspace conditions for products packaged under modified atmosphere and closure integrity, even where headspace is limited. The technology is designed to make Etalon effect negligible. It also removes any need for nitrogen purging during oxygen measuring.


The system features:

  • Low power consumption
  • Compact and lightweight design
  • Set-up via integrated PC or any wireless-connected touchscreen tablet or smartphone
  • Fully automated test cycle sequencing with manual loading and unloading of containers
  • Data storage and export (production, raw data, events, alarms)
  • Easy-to-use HMIU integrated functions
  • HMI real time display of statistics and raw data
  • Engineered to comply with FDA 21 CFR Part 11 and EU Annex 11

 

Please get in touch if you want to schedule a live demo or shoot us an email if you want to see it do the magic on a Virtual Conference.

Innovation Meets Sterile Manufacturing- Fedegari

 

Join us on October 19th at the new Berkshire Corporate Center, Lee (MA).
Don’t miss this opportunity to meet leading companies in the sterile manufacturing field and to learn through technical discussions and hands-on activities.

Learn more

Last spots available!

Don’t miss this workshop! A great opportunity to meet leading companies in the sterile manufacturing field and to learn through technical discussions and hands-on activities.

Book your spot here!

We look forward to meeting you in there!

Day 1 of Pack Expo

As day One of this year’s PACK EXPO Las Vegas comes to an end, we’d like to thank you all for connecting with us and meeting with our Project Engineer and Sales Rep Joe Skorcz.

If there is something that you wanted to ask or add to your meeting and didn’t had the chance or forgot to mention it, feel free to contact our office and discuss what you have on mind with the rest of Life Scientific, Inc. team.

We can bring you up to speed on the latest trends, technologies, innovations and insights to help your operations. We can assist you and help better understand how our equipment operates and why it could be the best solution for your facility.

Still not convinced?

Stop by our manufacturer’s booths at Pack Expo where you will see cutting edge technologies in action, investigate new solutions and leverage the education they can provide.

Please take note of our manufacturer’s locations

 

Bahnson Environmental Specialties
North Hall – Booth #304

The highest demanded Reach-In Environmental and Photostability Chambers in Vaccine storage.

 

 

 

 

 

 

 

Newman Labeling Systems Inc.
North Hall – Booth #437

Newman’s newly appointed Managing Director Shaun Baker will be in attendance.  Newman Labeling Booth is offering a Special Pack Expo 18% discount.

 

 

 

 

 

 

TASI Test Group
North Hall – Booth #209

TasiTest, leading specialist of packaging leak detection solutions, will showcase its latest product developments at Pack Expo Las Vegas on booth 209 in the North Hall.

 

 

 

 

 

Cozzoli Machine Company
Central Hall – Booth #2006

Cozzoli is exhibiting the FSV50 Mini Monoblock, the FPS2-SS Ampule Fill & Seal Machine. They’ll spotlight their tabletop equipment.

 

 

BONFIG LASERCUBE Live Demos

Overview

The BONFIG LASERCUBE from Bonfiglioli Engineering is a bench top system for performing Headspace Gas Analysis (HGA) analysis of sterile pharmaceutical containers, such as cartridges, ampoules and pre-filled syringes.

It provides a non-destructive, non-invasive laser-based inspection solution for leak detection and container closure integrity testing (CCIT) by measuring the headspace level of gases, such as oxygen and carbon dioxide, as well as monitoring moisture levels.

Design & Features

BONFIG LASERCUBE uses an inspection method created to meet specific customer requirements for s user-friendly solution to needs for ampoule, cartridge and pre-filled syringe leak testing and HGA.

The non-destructive, non-invasive laser-based inspection system is designed to measure the headspace levels of gases, such as oxygen and carbon dioxide, as well as monitoring moisture levels.

HGA is an ideal solution for accurate investigation of translucent containers and pharmaceutical finished containers, as well as headspace conditions for products packaged under modified atmosphere and closure integrity.

The BONFIG LASERCUBE measuring system ensures extreme stability and accuracy in inspection even where headspace is limited.

This is a compact and lightweight system that is easy to use and set up via integrated PC or any wireless-connected touchscreen tablet or smartphone.

The technology is designed to make Etalon effect negligible. It also removes any need for nitrogen purging during oxygen measuring.

User benefits:

BONFIG LASERCUBE is designed to meet the needs of Quality Assurance, Production, Maintenance, Production or Laboratory analysts in pharmaceutical companies producing sterile products. The solution delivers an impressive set of user benefits:

  • Non-invasive and non-intrusive inspection method
  • Near elimination of Etalon effect
  • Fast, reliable and repeatable results
  • Nitrogen purging not required during oxygen measuring
  • Compact and durable design
  • Maintenance-free
  • Quick changeovers
  • Cost-effective solution with low power consumption
  • Fully automated test cycle sequencing with manual loading and unloading of containers
  • Data can be stored and exported (production, raw data, events, alarms)
  • Enhanced easy-to-use HMIU integrated functions
  • HMI real time display of statistics and raw data
  • Validation package guarantees complete and efficient regulatory compliance

 

All TASITEST computerized systems are engineered to comply with FDA 21 CFR Part 11 and EU Annex 11.

Live demonstrations

Bonfiglioli Engineering formally launched the BONFIG LASERCUBE at the Interpack 2017 exhibition in Dusseldorf.

The Laser Cube debut in USA is going to be at this year’s Pack Expo Las Vegas at TasiTest booth N-209 therefore we invite anyone interested in the system to attend live demonstrations at the TASITEST’s booth.

Demonstrations will take place every morning and afternoon on each day of the show, if you want to get more up close and personal with this equipment schedule a demo at your facility at time that is most convenient for you.

 

 

Reservations for demonstrations can be made by emailing or calling Life Scientific, Inc. at:

MaryBeth:

Email: marybeth@lsi1.com                                               Phone: +1 800-829-5741

Piero:

Email: ppolastri@tasitest.com                          Phone: +1 414-335-5973

GET A FREE TICKET AND VISIT OUR MANUFACTURERS AT THIS YEAR’S PACK EXPO LAS VEGAS

Bahnson Environmental Specialties
North Hall – Booth #304

The highest demanded Reach-In Environmental and Photostability Chambers in Vaccine storage.

 

Newman Labeling Systems Inc.
North Hall – Booth #437

Newman’s newly appointed Managing Director Shaun Baker will be in attendance.  Newman Labeling Booth is offering a Special Pack Expo 18% discount.

 

 

TASI Test Group
North Hall – Booth #209

TasiTest, leading specialist of packaging leak detection solutions, will showcase its latest product developments at Pack Expo Las Vegas on booth 209 in the North Hall.

 

Cozzoli Machine Company
Central Hall – Booth #2006

Cozzoli is exhibiting the FSV50 Mini Monoblock, the FPS2-SS Ampule Fill & Seal Machine. They’ll spotlight their tabletop equipment.

 

 

Vetromeccanica S.r.l. – Conveying Solutions
Stefano Lodi, in Attendance

Specialized in conveyors and accumulating tables for loose and packed containers, make sure to connect with Stefano who will provide details on their fleet of Conveying systems. Contact Stefano beforehand to schedule a meeting by emailing him:
s.lodi@vetromeccanica.it

 

Aseptic Enclosures
Represented by Joe Skorcz,
in AttendanceIf you would like to meet with Aseptic Enclosures during Pack Expo to discuss any projects we can help you with, please contact our attending representative Joe Skorcz prior to 9/24 at:
o. 800-829-5741
c. 312-545-2164
JoeS@Lsi1.com

To get a Free ticket for this year’s Pack EXPO Las Vegas, follow the link bellow and register yourself as an attendee using the comp code: 43D42

http://bit.ly/PackExpoLV17

Enter it in the “comp code” box during registration.

By entering the code we provided you get your PACK EXPO ticket free of charge! By entering our code the ticket fee will be removed at check-out, where the fee will be waived automatically.

Meanwhile take a note of our Manufacturer’s Booth locations and our Reps in attendance and do not hesitate to get in touch.

Defining “Primary” Gas Flow Technology

All gas flow calibrators are not the same. Not only do the products vary, but the technology may as well. A calibrator that uses the International System of Units (SI base units) of time and length to derive gas flow measurements can be considered “primary technology”. Secondary technologies use proxy methods such as differential pressure to assume gas flow.

The seven SI base units are length, time, mass, electric current, thermodynamic temperature, amount of substance, and luminous intensity. Since there is no SI base unit for the direct measurement of gas flow, the base units of time and length are used to calculate flow rates.

Mesa’s DryCal technology uses a glass tube with a precisely known volume and a moving piston that triggers light sensors. Thus, the working principles of DryCal technology use the SI base units of time and length to calculate gas flow, making it one of the only primary technologies on the market.

When considering gas flow calibrators, be sure to look for an instrument that provided accurate, reliable, primary gas flow readings. Consider a name you can trust, such as DryCal from Mesa Labs, with over a quarter century of experience in the flow calibration industry.

Want to learn more about the science behind Mesa’s Primary Gas Flow Calibrators? Watch this video.

Source:

http://www.industrialhygienenews-digital.com/industrialhygienenews/summer_2017?pg=18#pg18