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/

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.

 

LATEST DEVELOPMENTS: INTEGRATED SOLUTION FOR STERILE ANTIBIOTICS

Fedegari Group was chosen as the preferred supplier of contamination control systems for a multinational pharmaceutical company with a new sterile antibiotic powder plant. The main challenges of the customer were to optimize the powder filling process and benefit from the cost-effectiveness of process integration with the best ergonomic design for the operators as well as ensuring a reliable and safe pharmaceutical process.

 

Cost-effective Solution for Filling Al-kegs with Sterile Antibiotics

Fedegari Engineering Team has worked with the customer for developing the most efficient and reliable solution that would allow to fill the containers (kegs) in the safest way for the product and for the operators. The outcome is a complete plant that combines in a modular way various subsystems which have been individually tested by Fedegari for different applications thus minimizing the risks typically associated with novelties. The solution also represents the most compact design for this type of operations.

 

Filling Al-kegs with Sterile Antibiotics

Fig. 1 – Removing the Al-kegs from the washer rack

 

Fedegari was choosen as the only manufacturer able to supply the process equipment (Washer-sterilizer) integrated with RABS and surface bio-decontamination with hydrogen peroxide MAL (Material Air-Lock).

The Project

A Washer-sterilizer integrated with RABS and bio-decontamination with hydrogen peroxide MAL applied to the system. The washer unloads on module 2 – RABS.

Module 1: Washing-sterilization

Module 2: Washed kegs unloading station

Module 3: Empty kegs buffer station

Module 4: Manual powder dosing, capping and bagging with automatic pneumatic lifting device. Packaging materials and tools are introduced through the hydrogen peroxide MAL connected to the module.

Module 5: Filled and packed kegs unloading station

Thema4 process controller delivered to the customer will be completely integrated with SCADA system.

Cost-effective Solution for Sterile Antibiotic Powder Filling of Al- kegs

Integrated Solution for Sterile Antibiotic Powder Filling of Al- kegs

Cost-effectiveness & Results

This solution helped the customer to achieve the desired ergonomic results on manual operations reducing the risks of contamination due to the integration of different machines connected by the RABS into one unique system managed by a single process controller.

 

ERGONOMIC DESIGN – Unloading system designed to work at the same level (height) throughout all the modules – from the washer to the RABS.

 

SIGNIFICANT TIME AND COST-SAVINGS by easily handling the kegs through sequential workflow inside the RABS.

 

CUSTOMIZATION – Modular & custom-made loading racks

 

COST-EFFECTIVENESS – Time and cost-savings on training and maintenance due to standardization of components, procedures and process controller.

 

ST100 Recirculating Hot Air Tunnel by Cozzoli

The ST100 recirculating hot air tunnel is designed for drying and sterilizing glass containers, particularly when used in a production line in the pharmaceutical industry. The tunnel uses vertical hot laminar airflow, under a class 100 air protection hood, to ensure the glass containers are not contaminated by any outside environmental contagions.

 

 

 

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.

Bonfiglioli will attend 2017 PDA Visual Inspection Forum

North Bethesda, MD, U.S.A., Oct 23 – Oct 24, 2017, tabletop # 209.

 


 

The 2017 Visual Inspection Forum, that take place in North Bethesda, MD, U.S.A. in the beautiful location of Bethesda North Marriott Hotel & Conference Center, continues to be an important element of the manufacturing process and the quality assurance of injectable products.

During the event case studies will be provided, new USP chapters<790> and <1790> will be explored, new developments in the field of visual inspection will be discussed, including contributions to a basic understanding of the sampling and inspection process, practical aspects of manual and automated methods, and the regulatory and compendial requirements that govern them.

The meeting will feature an exhibition where attendees can see the latest in commercial inspection hardware and discuss production needs; TASITEST Packaging Test & Inspection, the leading specialist on leak testing, measurement and inspection, that provides dedicated solutions as non destructive Container Closure Integrity TestingVisual Inspection and Headspace Gas Analysis for Laboratory and in-line packaging markets, will be present at tabletop # 209.

The complete and detailed agenda of the event and TASITEST tabletop can be consulted at PDA website https://www.pda.org/global-event-calendar/event-detail/2017-pda-visual-inspection-forum under “AGENDA”, “BROCHURE”,“FLOOR PLAN” sections.

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.