Ferndale Contract Manufacturing at ECRM 2016

ecrm

Let’s Meet in Chicago/Oak Brook

The FCM team will be attending this year’s ECRM show at the Hilton Chicago/Oak Brook Hills Resort & Conference Center in Oak Brook, Illinois next week from Sunday July 17th, through Tuesday, July 19th. We will be meeting with potential new Contract Development and Manufacturing customers in our meeting room through the weekend. If you’d like to schedule a meeting, please don’t hesitate to contact us in the form below. We look forward to meeting you!

For more information on the event, please visit their website by clicking here.

AMD: Analytical Method Development

When looking for a company to provide analytical method development services, one should look for two key qualities:

  1. An AMD team experienced in a variety of method development and validation projects with a proven track record in developing and validating analytical procedures used for clinical and marketed products
  2. An AMD lab equipped with modern cGMP instrumentation, especially HPLC, UPLC and GC capabilities with multiple detectors and software designed to evaluate peak purity and identity

The ADM leadership team at Ferndale Contract Manufacturing has over 100 years of combined experience in analytical chemistry and method development.

  • Tim Hurley: AMD Supervisor. 35 years of method development and Quality Control experience in the pharmaceutical industry. Author on over 25 publications ranging from preparative chromatographic isolations to the separation of antibiotics, steroids and pharmaceutical degradation products. Inventor on over 10 U.S Patents.
  • Linda Napoletano: AMD Senior Analyst. 20 years experience in analytical method development, QC analyses on raw materials, finished products and products on stability. Expert on data storage and security.
  • Melissa Klimaczak: AMD Analyst. 15 years experience in analytical method development, QC analyses on raw materials, finished products and products on stability.
  • Alice Ginter: AMD Manager. 35 years experience in the pharmaceutical industry.
  • Dr. Leon Dupuis: VP Quality Control and Validation. 35 years experience in pharmaceutical method development and validation activities.

In the past 5 to10 years, we have seen major advancements in: HPLC, UPLC chromatography and Software, especially with new instrumentation, detectors and HPLC/UPLC column chemistry. For example HILIC columns, new UPLC column bonded-phase (column) chemistry allowing for improved analyte separations; User friendly Mass spectral detectors, and RI detection with improved baseline stability;

But technology isn’t the only thing that has influenced the evolution in AMD. Regulatory agencies worldwide including the FDA, EP, JP, etc, have steered analytical method development and validation in profound ways. The regulatory agency requirements for testing various attributes of different products have steadfastly influenced the development of new methods, not only for the potency and purity of products, but also for the determination of essential physical properties of products.

If you’d like to learn more about AMD, or any of the other services Ferndale Contract Manufacturing provides, please call 877-548-0122 or fill out a contact form on our website.

DQSA Compliance

On November 27, 2013, President Obama signed into law the Drug Quality Security Act (DQSA) which is being implemented over the course of 10 years. Once the DQSA is fully in place, it will provide the consumer protection against unknowingly obtaining and using counterfeit prescription drugs, as well as creating an efficient approach to recalling a product in the unfortunate situation that one needs to be removed from the supply chain. Understanding what a large undertaking this is for the pharmaceutical supply chain industry, deadlines and benchmarks have been identified and are already being met with January 1st, 2015 being the first milestone followed by several others ending in November 2023.

The first notable deadline relevant to FCM and pharmaceutical manufacturers, took place in January 2015 in which the requirement to send trading partners an electronic transaction report was implemented. The industry recognized that most manufacturers were not ready, and delayed the implementation date to May 2015. FCM was ready in January, already sending transaction reports which included the product information, the transaction statement and the transaction history in one electronic document. This same ahead-of-schedule mentality is continuing on with the next several deadlines.

November 27, 2017 is the next deadline which will directly affect FCM’s daily operations. This step in implementing the DQSA will require FCM to place a serial number onto each saleable Rx unit. This unique identifier, specific only to that unit, will provide business partners, pharmacies and customers the ability to trace each specific unit back to its manufactured origin with greater ease. This traceability will now be able to be done quickly, with complete transparency of when/where the product changed hands; beginning with manufacturing and ending with the consumer. This November ’17 deadline is also important because manufacturers like FCM will no longer be allowed to ship Rx products without serial numbers. As demonstrated with the 2015 deadline, FCM customers and business partners can rest assured that FCM’s team is well ahead of schedule in meeting this deadline. FCM has created a talented task force of key departmental leaders which has been working vigorously to maintain an internally mandated timeline that is well ahead of the federally required schedule.

By November 2023, full aggregation of the saleable Rx products will need to be in place. This pedigree will create a traceable picture for each unit as it traveled through the supply chain. Traceability from the pallet, to the case, to the bundle and finally to unit level will be possible with the electronic sharing of these pedigrees – all which begin with the manufacturer, such as FCM.

As one can imagine; these federal requirements aren’t easy, or cheap to implement, but once in place, they will help to instill confidence and comfort into the customer by knowing that the prescription drug which they are taking for themselves, or administering to a loved one, is legitimate and was indeed manufactured in a FDA regulated facility…and that, in our eyes, is well worth the cost.

If you’d like to learn more about AMD, or any of the other services Ferndale Contract Manufacturing provides, please call 877-548-0122 or fill out a contact form on our website.

Full Speed Ahead: High Speed Tube Fillers for Gels, Creams and Ointments

What to Look For in High Speed Tube Fillers

If you’ve decided that a tube is an ideal container in which to package your gel, cream or ointment, contemporary technology provides an ideal solution in the form of high speed tube fillers. Packaging product quickly so it can become part of the supply chain is critical in any product life cycle, and utilizing a high speed tube filler can only create an advantage in the marketplace.

There are three main questions to consider when deciding on a packaging partner to provide a high speed tube filler service:

  • How flexible is the equipment and can it quickly and efficiently be setup for a variety of sizes and fill volumes?
  • Have they demonstrated consistency with regard to fill volume and seal quality?
  • Is the staff experienced with an understanding of the nuances of heat sealing?
  • Do they have a good preventative maintenance program in place?

Ferndale Contract Manufacturing answers in the affirmative to all of the above questions. Furthermore, our deep understanding of the obstacles involved in this process and of the high speed tube filler equipment we employ to complete the job is unparalleled in the industry.

Does Speed Sacrifice Accuracy?

Absolutely not. Our high speed line is equipped with an in-line checkweigher that provides constant feedback to the filler so the correct net weight is always dispensed. The equipment has also been proven through validation to constantly provide high quality tube fold and tube seals and correct orientation. Because the line is fully integrated, there is nominal handing of the tubes yielding less denting or damage to the tubes.

Why Ferndale Contract Manufacturing is an Ideal Partner

Ferndale Contract Manufacturing is the best provider for high speed tube filling because we have an expertise and wide variety of capabilities as it pertains to a product’s tube material, diameter, viscosity and fill weight. Currently, our portfolio accommodates tubes as small as a 3g and as large as 130g – all at speeds of 100tpm or greater.

Contact us toll free at (877) 548-0122 to learn more about us.

What’s the Difference between UPLC and HPLC?

UPLC and HPLC are both used to separate components found in mixtures. However, the similarities in these liquid chromatography techniques end there, as UPLC (Ultra Performance Liquid Chromatography) operates at higher pressures (15,000 psi) and allows for lower particle sizes in columns, while HPLC (High Performance Liquid Chromatography) operates at lower pressures (max 500-6000 psi). This presents an advantage over HPLC in improved analyte separation and detection, lower solvent consumption, and shorter run times.

Ferndale Contract Manufacturing has over 30 years of experience employing HPLC techniques and has started utilizing UPLC systems over the last four years. The main advantages of UPLC over HPLC are rapid turnaround times for analytical testing, and enhanced separations and optimal product profile on an analytical scale. HPLC is still available, used when transferring or developing and validating an existing compendial method that already uses HPLC.

Ferndale Contract Manufacturing’s QC analysts have over 100+ combined years of analytical chromatographic experience. This experience guides the development and implementation of methodology that is the best fit for a given application.

If you’d like to learn more about UPLC and HPLC, or any of the other services Ferndale Contract Manufacturing provides, please call 877-548-0122 or fill out a contact form on our website.

Looking for a versatile packaging solution? Consider Foil Pouch Packaging.

Foil pouch packaging is an ideal method of packaging topically applied products such as creams, gels, and ointments. Even solution fills are a good fit, as a wipe can be inserted into the foil pouch packaging for application of the product. But versatility isn’t the only benefit.

Compared to other methods, foil pouch packaging has tremendous cost savings over using a tube or a bottle, and is used mainly for single unit doses of products or samples. The flexible laminate foil pouches are also ideal for products that may be light, oxygen or moisture sensitive because of their excellent barrier properties.

At Ferndale Contract Manufacturing, we utilize an Enflex F-11-T Fill, Form and Seal machine to provide our foil pouch packaging services. This state-of-the-art machine runs at high speeds and is adaptable to many different configurations. It is also capable of inserting a woven or non-woven wipe. We can also provide a child resistant closure complaint with the Consumer Product Safety Commission for products requiring this type of closure.

Limiting foil pouch packaging defects is an important part of our operating procedure, and our knowledgeable staff has over a decade of experience in filling and sealing laminate structures. Furthermore, the machines we utilize have measures to: ensure accuracy of fill with nominal variation and no drift, even during multiple week runs; detect and auto reject dry or missing towelettes; and ensure accurate count of finished wipes through a counting and grouping conveyor.

Ferndale Contract Manufacturing is a cGMP compliant, FDA registered prescription drug manufacturer that can use this equipment to fill Rx (prescription), or OTC drugs or cosmetics. The equipment is brand new, and Ferndale currently has excess capacity and machine time available. Along with filling the products into foil pouch packaging, as a fully integrated company, we can also offer development, scale up, compounding, and full release testing for all products.

If you’re interested in learning more about our foil pouch packaging services or any other services we provide at Ferndale Contract Manufacturing, please call us Toll Free at (877) 548-0122.

New Enflex F-11-T Pouch Filling Machine

Ferndale Contract Manufacturing has enhanced its offering to customers by recently commissioning an Enflex F-11-T pouch filling machine. The new equipment manufactured by ACMAVOLPAK, has been designed for the forming of thermo-sealable flexible material. The machine is equipped with an optional towelette folding and insertion station. When enabled, the folded towelette will be inserted within the formed pouch simultaneous with the dispensing of a liquid solution.
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