Montesino | Pharmaceutical Packaging | Packaging Industry News
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On Thursday (June 6, 2019), Peter Schmitt gave a talk entitled “Cannabis Packaging: Balancing Branding & Requirements.” In the talk, Montesino detailed the existing and compliance regulatory situation in Canada, detailing the packaging and labeling regulations for cannabis. The talk also went into depth on how those regulations impact branding of cannabis products in Canada. The talk ended with the announcement of the Cannabis Packaging Summit, to be held February 11th and 12th, at the MDM West event in Anaheim, CA. Information about the Cannabis Packaging Summit can be found at https://cannabis-pack.com/
Questions and discussion at the end of the talk focused on the challenge of packaging given the detailed packaging and labeling regulations. There was also discussion on how to balance safety and packaging issues with the drive to eliminate waste, and questions about how these packaging regulations will compare to the fluid situation south of the border. More information on this upcoming event will be published shortly.
On Wednesday (June 12, 2019), Peter Schmitt gave a talk entitled “Packaging: The Last Mile in Medical Cannabis.” In the talk, Montesino detailed the existing regulatory situation, exploring both the implications of Federal Law (Schedule 1) and the various State Laws that authorize the use of medical cannabis in a given state in spite of the federal situation. The talk also went into depth on key medical cannabis packaging issues: Safety (Child Resistant Packaging), Efficacy, Compliance, and Harmonization.
The talk included with a call for harmonization of packaging regulations: between the various US states and the Federal government, between the US and Canada and eventually, globally harmonization.
The talk ended with the announcement of the Cannabis Packaging Summit, to be held February 11th and 12th, at the MDM West event in Anaheim, CA. Questions at the end of the talk focused on the concept of packaging as “the last mile.” There is intense interest in understanding the regulatory and compliance issues, as well as the type of packaging containers and performance issues they will face. More information on this upcoming event is available at https://cannabis-pack.com/
On May 28th in Guadalajara and May 30th in Mexico City, Montesino’s Peter Schmitt gave a keynote presentation on high barrier packaging optimization at Novaprint’s 6th Seminar on Packaging Innovation. Joining other industry speakers, including Constantia, HPT Pharma, Körber Medapak and the event sponsor, Novaprint, in addressing flexible packaging challenges in Mexico and the Central American region on the future. The talk focused on exploring Quality by Design concepts, “Critical Quality Attributes” and “Critical Process Parameters” to answer the question surrounding packaging problems and inefficiencies: “Is it the material or is it the machinery?” Schmitt’s talk noted that, especially when looking for innovations and improved efficiency, rather than “playing the blame game” or “looking for a silver bullet,” a process is needed to move towards root cause analysis and continuous improvement. Both talks were well attended, with close to 100 packaging professionals present in Guadalajara and 200 in Mexico City. Two additional critical issues were focus points: developing an understanding of the difference between “price” and “cost” and the challenges facing the use of PVC as a flexible material in the future. A large number of younger professionals drove the later issue with an intensity not seen in some time. Both sessions concluded with a high degree of participant participation and satisfaction with the vent.
The FCE show began at 11:00 on Tuesday, with a large selection of exhibitors and attendees. The hall is divided into a pharmaceutical and a cosmetic section; many of the exhibitors’ locations are based on spaces they’ve used year after year for more than a decade. Here are some first impressions…
Flexible Packaging News
Novaprint – Constantia
Novaprint-Constantia booth at FCE 2019
Novaprint presented its anti-counterfeiting technology in lidding products, in partnership with Constantia Flexibles, the global leader in aluminum laminates and structures. The technology uses an invisible lacquer visible only with UV light as well as two sided printing to increase obstacles for counterfeiters.
Novaprint continues to expand its presence in Brazil with its plant in Atibaia. Current capacities include slitting and printing, up to six colors, as well as robust inventory for just-in-time supply of lidding and forming films.
This year at FCE ACG is highlighting its continued expansion in Brazil, both in packaging and in capsules. Dr. Erwin Pasbrig is speaking about aluminum based packaging materials for blisters. His talk introduces new structures for Cold Formed Foil (Alu/Alu) that offer increased barrier and protect against cross migration to give the customer an alternative to foil laminates with desiccants. In addition to aluminum based structures, ACG also offers high barrier formable polymer structures, both Aclar® based films and the newer “SuperB” high barrier PVdC structures.
ACG is also showcasing its tablet presses and capsule filling machinery, well known internationally and growing rapidly in Brazil.
This is (presumably) the last show when Amcor and Bemis will each have a stand, as the deal is expected to close in the immediate future. Some decisions on what the new Amcor will look like are now known.
All of Amcor Latin America will report to Aluisio Ragazzi Fonseca. Adrain Fugante, currently the General Manager of Amcor Brasil, will become Vice President of Healthcare in Latin America. More details are expected in the next 4-6 weeks.
There is a certain sense of history in Brazil regarding this acquisition. It was not that long ago that Amcor and Bemis each bought a portion of Alcan Packaging, at the time the major player in pharmaceutical foil packaging. As Mark Twain noted, “history may not repeat, but it rhymes.”
Honeywell is introducing a new Aclar® product, Accel, during the event. The officering includes two new clear and opaque laminated options for its high-moisture barrier films, Aclar Accel 1700 maintains the clarity, but has a standard size that allows for faster production and delivery to companies at a lower cost. Aclar Accel 5400 is designed for opaque laminates and offers a denser, moisture-rich barrier to companies seeking a more cost-effective solution to protect drugs than cold form foil in aluminum blister packaging, which has higher production costs and slower output.
Bilcare is growing its presence in LATAM with more to come. There is an ongoing exploration of how to be both global and local. They offer the full range of products, polymers to aluminum, with a focus on high barrier structures. Nelson Matsuo and Silvina Berasay are leading this charge; Nelson based in São Paulo, Silvina in Buenos Aires, Argentina.
Daniel Hiddink, managing director, indicated that hMh is very busy in Brazil and in LATAM. Last year set new sales records and the company looks to continue with strong growth. Marion Scherer handles sales in Brazil, which are growing rapidly after patient years of work.
Brazil’s pharmaceutical and cosmetic market come together annually at the FCE Show. The trade show lasts for three days, traditionally Tuesday through Thursday, but Monday night for the past 23 years is a special night – where Sindusfarma announces the annual Quality Awards.
Sindusfarma has no easy equivalent outside of Brazil, click here for more information on the organization. Starting 23 years ago, it organized a competition among suppliers to the pharmaceutical industry focusing on quality. The competition is, frankly, quite intense, and the award ceremony resembles in many ways the Academy Awards or other similar such events.
In primary pharmaceutical packaging, this year’s winners were:
Primary Packaging for injectables: Schott
Primary Packaging for blisters: Klöckner Pentaplast
Primary Packaging for bottles and caps: Gerresheimer
Primary Packaging for Foil lidding: Diadema
Award Winners at Sindusfarma
This year’s ceremony also awarded Dr. Lauro Moretto special recognition for his 40+ years of service to the pharmaceutical industry. In packaging, Dr. Moretto’s work includes the publication of Sindusfarma guides on Packaging, Quality Standards and Qualifications of Packaging Materials and Machinery.
The recent announcement of the cessation of manufacturing BOPA and OPA films at AdvanSix’s Pottsville, PA plant brought to mind Dylan’s 60s classic about change. Dylan released that song in 1964; in 1961, Allied Chemical began extruding nylon (polyamide) and other materials in Pottsville, PA. Those times were best captured by the famous quotation from Mr. Maguire to Benjamin Braddock in the Graduate, “One Word, Plastics!”.
The Graduate "One Word: Plastics" - YouTube
And in Pottsville, the mandate was to take specialty plastic resins and make high-performance films out of them. Roughly 58 years later the times indeed have changed. It is a good time to reflect on those changes.
Film properties come from essentially two areas: the raw material(s) used in their production and the machines used to process those materials into film. In earlier times, well before the first oil shock, plastic raw materials were cheap, production machines required skilled operators and technical leadership to make those films, and end-user markets compared the plastic film pricing to alternative materials, usually glass or metals, and found most pricing to be quite attractive. This often meant that on a per unit basis (lb., kg., MSI, etc.) the film processor captured, with relatively little pressure, healthy margins for processing resin into film.
Initial Inflection Point
Starting with the oil shocks in the 70s, this changed. The price of the raw material took off at the same time end users grew in sophistication and begin to compare pricing between suppliers of plastic materials, not plastic against glass or metal. While raw material prices trended ever higher, film processing margins decreased. Ironically the most obvious solution short term, producing more film per hour, actually over time increased the margin squeeze on film processors while supporting resin manufacturers’ focus on increasing volumes. Perhaps in no film processes is this clearer than in BOPA and BOPP. Production efficiency (either tons or m² per hour) meant buying ever more expensive equipment, while end users became more sophisticated in negotiating price.
Challenges & Changes Today
The Pottsville announcement points to this challenge. Today nylon 6 6 supply is tight, pricing increasing, forcing film processors to buy ever larger machines. Clearly, both the resin suppliers and the OEMs win in this scenario. It is extremely difficult to win processing resin into film. The times they are a-changin’ – it will be interesting to watch whether transferring the film production to new, larger lines south of the border “fixes” this margin squeeze or simply moves it to another processor.
PROCESSORS SUCCESSFULLY CONVERT ANOBEX® RESIN INTO FILM AND COMPONENT PARTS
TRUCKLOAD DELIVERIES BEGIN
$USD 17.5 MILLION CAPEX ASSURES SUPPLY CHAIN SECURITY
MSM POLY recently completed shipments of several tons of material to film and component processors. The material processed well and was then sent to converters, who are currently sending samples to pharmaceutical end users. All results today demonstrate equivalence with the discontinued Barex® resin. This event marks a milestone in product quality and production security.
Pat Mickle, CEO of MSM POLY, noted that “these first commercial scale orders demonstrate the stability of MSM POLY’s production processes and quality program to meet and exceed requirements of pharmaceutical end users.” Many end users will now accelerate the approval process to use Anobex® in a wide variety of pharmaceutical applications. Supporting this effort, Steve Warakomski, MSM POLY’s CTO, noted the development of an equivalency portfolio to aid end users in the approval process.
Michel Rauturier, Managing Director at Plastiques Venthenat, a major producer of acrylonitrile methyl acrylate copolymer latex films based in France, noted that “the resin processed well and both in terms of initial testing of properties and performance shows equivalence with Barex®.”
MSM POLY’s initial CapEx of $5 million will increase to $15 million in 2018, and the company spent an additional $2.5 million in R&D to reach this milestone. Dan Mullock, COO at MSM POLY, noted “Now that we are producing commercial quantities, end user customers are rapidly confirming that our material is an equivalent, ‘drop-in’ replacement for Barex®. This milestone is important for regulatory and quality assurance programs, and for the security of the supply chain.” It marks the rebirth of a specialty polymer.
Capacity is being added so that by the 2nd Quarter of 2018 MSM POLY can produce sufficient quantities for the market. Additional expansion is expected as demand for the product increases.
MSM POLY currently offers processors Anobex® resin as pellets for film and sheet extrusion and injection molding as well as powder for calendering, coating, and compounding. The material is undergoing validation in Europe, North America, and Japan.
MSM POLY LLC was created for the express purpose of producing acrylonitrile methyl acrylate copolymer latex resin for the global packaging industry. MSM POLY is financed and led by Patrick Mickle, who in 1982 created and led Kelcourt Plastics, Inc., a leading supplier of custom extrusions to the medical device industry. Industry experts Dan Mullock (COO) and Peter Schmitt (CSO), join Mickle in filling an industry need for a specialty barrier product.
MSM POLY’s European distributor, VELOX GmbH is a regional leader in the marketing and distribution of raw material specialities for the plastics, composites, additives and paints and coatings industries. Founded in 1993 by Bernard Goursaud and N. Max Schlenzig, VELOX is headquartered in Hamburg, Germany. The company has 18 offices throughout Europe and employs over 200 experienced employees to support its customers.
After the dates listed below, eCTD requirements for submissions to CDER and CBER will go into effect and submissions that do not use eCTD will not be filed or received.
May 5, 2017: New Drug Applications (NDAs), Abbreviated NDAs (ANDAs), and Biologics License Applications (BLAs), must be submitted using eCTD format.
May 5, 2018: Commercial Investigational New Drug Applications (INDs) and Master Files must be submitted using eCTD format.
This update impacts two groups in pharmaceutical packaging, and if you belong to one of these two groups, you need to execute a plan as soon as possible.
Holders of Type III DMFs.
Holders of Submissions that cite (include references) to Type III DMFs.
If you belong to either of these two groups, please note the following important information.
Holders of Type III DMFs
Effective May 5, 2018, the FDA requires that all DMF submissions be in eCTD format. If they are not received in this format, your submission will be rejected. This includes all any submissions to your existing DMF, such as LOAs, Annual Reports and Amendments. Of course, any new DMF will be required to be submitted on the eCTD format.
What is not required
You are not required to re-do the original DMF in eCTD format at this time. Please consult with Montesino or another expert, however, if you plan to reorganize or make significant additions to your DMF, as under these circumstances it may be in your best interest to convert your existing DMF into eCTD format.
What is required
eCTD submissions sized 10 GB or less must be submitted via the Electronic Submissions Gateway (ESG) – this includes the vast majority of Type III DMFs
Electronic Submissions must use the eCTD version currently supported by the FDA (this is subject to change). https://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/ucm2005545.htm
The Holder must obtain a pre-assigned application number
All content submitted (whether as simple as the annual commitment letter or more complex submissions) must adhere to FDA file format types using eCTD specifications and FDA PDF specifications. There are additional FDA requirements in the case of more complex operations. /li>
Letters of Authorization (LOAs): Will need to be in a specific section of the DMF.
3.1.8 Letters of Authorization
Letters of Authorization (LOAs) should be submitted in Section 1.4.1 of the DMF. The copy of the LOA that is sent by the DMF holder to the Authorized Party (company or individual authorized to incorporate the DMF by reference) should be placed in Section 1.4.2 (“Statement of Right of Reference”) within the Authorized Party’s application.
Holders of Submissions that cite Type III DMFs
Manage the risk of delays due to suppliers (holders of Type III DMFs) having deficiencies as they do not meet eCTD requirements by May 5, 2018.
Develop resources required to monitor supplier readiness.
CONCLUSION – THE CLOCK IS RUNNING
Both holders of Type III DMFs and companies holding submissions that reference Type III DMFs need to move now to prepare for this deadline. Contact Montesino (or the expert service of your choice) today to review these issues.
Finally, if you also hold a Canadian Type III DMF, contact us immediately! We will send additional information.
Pharmaceutical packaging suppliers have just one year before all U.S. Drug Master Files (DMFs) will need to be submitted electronically. As we explained earlier this year, DMF submissions and related documents will need to be filed electronically with FDA in the eCTD format by May 5, 2017, or they will be rejected. FDA states that there are no exceptions.
There is some concern that not all Type III DMF holders of packaging component and raw materials will be ready to meet FDA’s new eDMF requirements. Peter Schmitt, managing director and cofounder of Montesino Associates, told PMP News that “it is not clear that holders of Type III DMFs realize that ‘the clock is ticking.’ ” Frank Bieganousky, also managing director and cofounder of Montesino Associates, warns that delays could impact pharmaceutical companies that rely on DMF Letters of Authorization in their own FDA submissions. And Dwain L. Sparks of YourEncore expects the DMF changes to be “confusing to all parties.”