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












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,

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.


Vetromecanica specializes in tailor made and highly customized:

Bulk Conveyors
Air Conveyors
Table-Top Conveyors
Multipack Conveyors
Elevators / Lowerators
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,, 919-829-6074.


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 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.