Driving Change In Pharmaceutical Packaging-Newman Labelling

With the Falsified Medicines Directive coming into force in 2019, now is the time to re-evaluate the efficiency of your production lines to ensure they will cope with the extra demands the Directive will place on them.

In July 2011, the EU adopted the Falsified Medicines Directive in a concerted effort to protect patients and consumers from falsified medicines which may contain ingredients of low quality or in the wrong doses; be deliberately and fraudulently mislabelled with respect to their identity or source; have fake packaging, the wrong
ingredients, or low levels of the active ingredients. As you might expect, falsified medicines do not pass through the usual evaluation of quality, safety and efficacy, which is required for the EU authorization procedure. Because of this, they can be a very real health threat.  The Falsified Medicines Directive doesn’t comes into force until February 2019 but EU member states are under an obligation to start implementing the measures laid out in the Directive.

 

 

For pharmaceutical manufacturers, contract packers and distributors – indeed all those involved in the supply chain –
the new Directive is momentous. Whilst there have already been requirements for certain information to be included on the packaging, the Directive will require organisations to be able to proficiently handle vast amounts of extra data. That data doesn’t just need to be stored and archived, but will need to be applied to medicine packaging and read at high speeds. With the new Directive, every individual pack of medicine must be marked with a unique, non predictive serial number with information that can be read by people and machines; previously only data pertaining
to the batch was required, but the onus has now changed to each and every individual container. The unique identifier must be placed in a 2D barcode and contain the product code, a serial number, the national reimbursement number (if requested by Member States), the batch number and the expiry date. Each serial number must be registered with a pan European database.

Read more here: http://www.newman.co.uk/download_pdf/Driving-Change-In-Pharmaceutical-Packaging.pdf

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.

 

Fresenius Kabi Specify Newman Vial Labeller For Reliability And Output

Newman Labelling Systems, a leading manufacturer of pharmaceutical labelling systems, has supplied a 6VAL labelling system to health care company Fresenius Kabi for use in their Port Elizabeth facility in South Africa.

The 6VAL labelling system is designed to apply both clear and paper self-adhesive labels to a range of rigid cylindrical containers. At Fresenius Kabi it is being used to label 2ml vials of PETOGEN 150mg/mL Injection. The well proven 6VAL container handling system is specifically designed for handling unstable containers such vials, in addition to ampoules, syringes and cartridges, at speeds of up to 275 containers per minute.

The 6VAL has been supplied by Newman with a PCE Pilot Optical Character Vision and Optical Character Recognition system and a Videojet Dataflex Thermal Transfer Coder with colour screen for printing batch and expiry dates.

Fresenius Kabi’s decision to purchase the 6VAL was based on a combination of machine quality and capability, plus the reputation of Newman Labelling Systems both within the company and the industry at large. Jeremiah Thorne, Project Engineer at Fresenius Kabi, explains: “We were impressed by the output capacity of the machine, the presence of a unit rejection station, 2D barcode scanning option and the fact that it is cGMP compliant. We also liked Newman’s ability to supply the machine with OCV and OCR options.

“The other consideration in our decision was the brand name and the manufacturer’s expertise when it comes to developing and manufacturing labelling equipment for vials and ampoules. Newman’s machines have proved to be reliable and Newman has always provided a professional, efficient and helpful service, which has led us to standardise on them in our factory. “

THE GEOMETRY OF A PROCESS VESSEL- JVNW

The Complete Process Vessel is one where all components are perfectly matched for efficiency and performance. Cleaning devices must reach every corner but must not interfere with shafts and impellers. Instrumentation must be properly located to avoid false readings. Heat transfer jacketing must be sized for batch loads or zoned for flexibility. The same mechanical engineering talent that invented the patented Sanifoil and Easy Change SaniBearing steady bearing (patented 2008) continually solve the most difficult processing challenges. Instrumentation, mixer and vessel are designed as one, and undergo complete performance testing prior to shipment. JVNW pre-validation support is thorough and on time.

 

 

  • WFI Vessels
  • Bioreactors
  • Portable Transfer Vessels
  • Sterile Surge Vessels
  • Fermentation Vessels
  • Bio-storage Tanks
  • Kettles
  • Pilot Scale and R&D Vessels
  • Agitation Systems

ONE SOURCE

  • Mixer Laboratory
  • Ultra-sanitary Sanifoil Impeller,
  • solid shafts
  • Factory electropolishing
  • Controls, instrumentation, wiring:
    • level
    • temperature
    • pressure
    • ph
    • DO
    • conductivity
    • RPM sensors
    • displays
    • pressure relief
  • Complete mixer installation
  • Cleaning devices, fixed positioning, testing
  • Mixer and tank performance tested prior to delivery (FAT)
  • Pre-validation documentation packages

ASEPTIC PROCESSES: TECHNOLOGICAL INNOVATIONS ON A3P BARRIER TECHNOLOGY DAYS

ASEPTIC PROCESSES: OUR TECHNOLOGICAL INNOVATIONS

 

Barrier systems are developed and continuously updated technologies that reduce the risk of contamination during sterile aseptic manufacturing by “containing” direct human intervention in critical areas.

 

For the third consecutive year, the A3P Association has planned to dedicate two days of conferences on Barrier Technologies.

 

STERIGENE, our long-term partner and a major player for process equipment and contamination control, will be proudly receiving visitors on stand N ° 7.  Accompanied by Sergio MAURI, Manager, Global Integrated Projects at FEDEGARI GROUP, the STERIGENE team will present its technological innovations in aseptic processes and pharmaceutical isolators.

 

Featured products: Fedegari Sterility Test Cabinet – FCTS / Fedegari Isolator FCIS

 

FCTS – Fedegari Isolators for Sterility Testing

 

The FCTS isolator is a GMP process equipment equipped with a built-in H2O2vaporizer engineered and manufactured by Fedegari. It is mainly used for the sterility testing of pharmaceutical and cosmetic products.

Unstisfied with the performance and reliability of third-party hydrogen peroxide vaporizers, Fedegari has installed the same solutions that were standardized for its bio-decontamination units that do not require any proprietary consumables.
This innovative design provides real time biocide concentration control (over traditional estimate d calculations) and is managed by the very same Thema4 process controller which is today’s reference standard for all contamination control machines.
Through the H2O2 sensors, Thema4 assures that vapor concentration
remains extremely constant (within ± 15 ppm) thus making process repeatability
the logical consequence.

 

Download the complete product presentation – FCTS

 

017-sterility-test-cabinet-fedegari-copia

FCIS – Fedegari Isolators for aseptic processes

 

One of the special features of the Fedegari isolators (FCIS) is the possibility of coupling the equipment with a saturated steam autoclave or a chemical bio- decontamination with H2O2 lock, in order to create an aseptic transfer process for the complete sterility tests according to the GMP principles. The integration of these systems (sterilization + isolator / bio-decontamination + isolator) is a cost-effective solution for controlling the cross-contamination often induced during intervention of operators in critical zones.

 

In the pictures below you can see a moist-heat sterilizer (autoclave) integrated with a sterility test isolator for aseptic processing.

fof-fcts-dettaglio-019-2-2

Internal view -Steam sterilizer integrated with a sterility test isolator

fof-fcts-05-2-2

Steam sterilizer integrated with a sterility test isolator

 

 

If you need more information about the participation of STERIGENE & FEDEGARI in the A3P Barrier Technology Days or on our FEDEGARI aseptic process equipment, please contact us: sterigene@sterigene.com or fedegari@fedegari.com

 

Cozzoli Threadless Syringes

Cozzoli developed their threadless syringes to reduce mounting time, cut down cleaning time, and totally eliminate the possibility of cross threading.

All new Cozzoli/MRM machines will include these syringes.

This upgrade can be retrofitted easily to existing machines.

Parts Sale Reminder
  • 10% discount on parts for your summer shutdown.
  • Discounts on preventive maintenance
  • Consultation service call comped when recommended action taken *

Call us today and get your Cozzoli and MRM machines running with maximum performance!

Contact our Customer Service Department to find out how:
call 732-564-0400 or email custserv@cozzoli.com.

Choose JVNW for Fermentation Processes

Whether you’re making small amounts of cider at home or large quantities commercially, one thing is clear: you’ll need food-grade vessels to ferment and age it in. Our food and beverage grade stainless steel vessels are the best solution for your fermentation processes.

For cider fermentation in our case, we offer the closed top, variable capacity and bottom cone fermentation tanks. The variable capacity tanks are great for cider makers who have varying amounts of product at a given time. The floating lid may be raised or lowered based on the volume.

JVNW’s fermentation tanks are designed to contain apple juice, to which yeasts are added in order to convert the sugars into alcohol and carbon dioxide. The fermentation process is temperature-controlled to ensure that it develops at the ideal temperature, thanks to special hollow spaces in the tank’s cylinder in which a low-temperature glycol solution circulates.

JVNW bottom cone fermentation tanks are designed for full yeast extraction, yeast settles in the cone and may then be reused in the following fermentation process.

Our steel tanks and vessels limit the odds for apple rotting during fermentation, thus excluding the chance for patulin contamination. Patulin is a toxic chemical produced from a number of moulds such as Penicillium and Aspergillus. Although apples tend to be the major source, any mouldy or rotten fruit could contain this toxin.

 

Why JVNW? Because our stainless steel systems undergo a series of tests in our mixer testing laboratory prior to shipping, which outs any chance for translational process deviation during fermentation processes.

 

In order to get the best out of your business, you have to work with the best in the business, JVNW!

Easter Visit to Illinois-MC, LSI, MBE Fedegari Meets 4/17-4/18

 

Valued customers,

Life Scientific, Inc., wants to encourage you to reach out and get a hold of our top manufacturers best representatives this Easter in Illinois.

Our lead sales representative MaryBeth Eyer will be in the Chicago, Illinois area after Easter. She’ll be accompanied Joe Walsh, Fedegari’s Sterilization project manager on the Fresenius Kabi Caring for Life Congress. Sterilization plays a big part of patients’ safety and when it comes to the process of making procedures free from bacteria, pathogens and other microorganisms we provide the #1 solutions.

We guarantee to offer something unique in the general healthcare and pharmaceutical manufacturing world, designated to making it a place where the known risks for the end-users and the healthcare specialist are limited to minimum.

Sterilization is a vital part of the everyday life and can be implemented in the food and beverage processing, medicine and surgery, pharmaceuticals and even has its own place in space crafting.

It’s one of the most important processes that can be related to the overall health and wellbeing of the people.

Interested in meeting them and discussing the latest technologies, trends and solutions in sterilization processes call now and request an appointment while there is still time available in their schedule.

Schedule a meeting now and learn more about sterilization from the best first hand by calling Life Scientific, Inc.  Tel: 800-829-5741, 314-752-9400, 3720 Hampton Ave., Ste. 204 St. Louis, MO 63109.

RLD-400DC In-Line Leak Testing Solution from Bonfiglioli Engineering

In-line Leak Testing Machine for Filled Containers

Life Scientific, Inc. is honored to introduce a new TasiTest solution brought by one of our top manufacturers Bonfiglioli Engeneering. Reach us in order to get a quote.
This Leak Testing Machine is used for in-line Non-Destructive Container Closure Integrity Testing. It performs the Leak Testing process in continuous operation by means of Testing Chambers under Vacuum or optionally Pressure which are installed on to a rotating Central Carousel. Following Leak Testing process, the Containers are automatically unloaded from Testing Area and they are managed according to the result. Whether the result is Conforming or Non Conforming, the HMI clearly displays the status.

This state of the art Machine performs both Pressure Decay Method and Vacuum Decay Method, and it’s applicable to most pharmaceutical package systems, with guaranteed reliability of above 99 %.

Once the test chamber is loaded with the content that is going to be tested, any decay greater than a given threshold at end of the testing phase, points out a leakage, followed by organizational process where the containers are automatically unloaded from Testing Area and they are managed according to the result. The result of the test is shown on the visual board with a pretty simple and intuitive user interface.

Call us today for a quote! 1-800-829-5741