Archive for packaging line

Holst Center reports breakthrough in organic RFID

February 19, 2008 at 9:46 pm · Filed under California e-Pedigree, compliance packaging, packaging line ·Tagged , , ,

Holst Center reports breakthrough in organic RFID

We’ve achieved a significant leap forward in RFID integration into packaging rather than labels, which presents the prospects of aligning RFID with datamatrix costs.

While Siemens and Kurz owned PolyIC is proud of achieving an 8 bit printed polymer RFID tag, competing with BASF and Weyerhaeuser, Holst achieved a 64 bit 13.56 MHz plastic organic tag.

This achievement brings serialization capabilities closer to printed electronics and will bring item level serialization at a cost of a penny or two.  At least a plastic rectifier and plastic circuit is a significant leap away from silicon.

Holst Center (http://www.holstcentre.com), which was founded by the Belgian nanoelectronics research center IMEC and the Dutch research center TNO, have announced a plastic 64-bit inductively-coupled passive RFID tag operating at 13.56MHz. With a record 780bit/s data readout of 64 bits over 10cm, the device approaches item-level tagging requirements.

The tag generates a 5-fold higher bit rate compared to state-of-the-art plastic RFID systems. The achievement paves the way for low-cost high-volume RFID tags to replace barcodes. The RFID system consists of a low-cost inductive antenna, capacitor, plastic rectifier and plastic circuit, all on foil. The LC antenna resonates at 13.56MHz and powers up the organic rectifier with an AC voltage at this frequency. From this voltage, the rectifier generates the DC supply voltage for the 64-bit organic transponder chip which drives the modulation transistor between the on and off state with a 64bit code sequence. The foil with the transponder chip was processed with the state-of-the-art organic electronics technology provided by Holst Center partner Polymer Vision.

Organic vertical diodes have been used in the rectifier since they outperform organic transistors for rectification at frequencies at and above 13.56MHz. At an RF magnetic field strength of 1.26A/m the rectifier generates an internal transponder supply voltage of 14V. At this voltage, the 64-bit designed code is read out at a data rate of 787bits/s. The reading distance is up to 10cm. The organic 64bit transponder chip, fabricated by Polymer Vision (http://www.polymervision.com), is using organic bottom-gate p-type Pentacene thinfilm transistors from soluble precursor route. It comprises only some 400 transistors and is thereby significantly smaller than previous designs.

Unrelated to the Holst plastic RFID product, printed RFID is the fabrication of dual-gate organic thin-film transistors using plasma-enhanced atomic layer deposited 150  nm thick Al2O3 and 300  nm thick parylene as gate dielectrics and pentacene as a semiconductor. The threshold voltage (Vth) is changed from 14.5 to –1.5  V when the voltage bias of the top-gate electrode is changed from –10 to 20  V. The voltage transfer characteristics of an inverter with a dual-gate driver transistor and a single-gate load transistor, specifically, swing range and inversion voltage, have been artificially controlled by changing the voltage bias of the top-gate electrode.

About Holst Centre
Holst Centre is rapidly evolving into an internationally recognized center for open innovation in technologies for wireless autonomous sensor-based microsystems and systems-in-foil. Holst Centre was established in 2005 by the Flemish research centre for nanoelectronics and nanotechnology IMEC and the Dutch research institute TNO. From the start, it is financially supported by the Dutch Ministry of Economic Affairs and can count on the approval of the Flemish Government. Located on the High Tech Campus in Eindhoven, Holst Centre can benefit from the state-of-the art on-site facilities. Holst Centre has over 100 employees (growing to over 200 by 2010) and a network of over 15 industrial partners. More information: www.holstcentre.com

About Polymer Vision
Polymer Vision is the pioneer and mobile industry leader of a revolutionary new generation of mobile devices enabled by rollable displays. The company’s first product, the Readius®, is a pocket sized device combining a large 5″ rollable display with 3G high speed connectivity. It is designed around ‘always available’ and ‘real time updated’ personalised news and information of the user. The Readius® is the first member of a family of Polymer Vision products that will offer consumers large rollable displays (5″-to-9″) in small pocket size devices. These devices fulfill a growing demand for larger mobile displays to compliment the accelerating trend towards mobile content, applications and mobile advertising. In 2007 Polymer Vision was the winner of the 3GSM Global Innovation Award. In October of 2007 Polymer Vision acquired the whole of the business activities of Innos Limited UK, the manufacturing subcontractor of the company’s rollable displays and integrated this into Polymer Vision Ltd. More information: www.polymervision.com

About IMEC
IMEC is a world-leading independent research center in nanoelectronics and nanotechnology. Its research focuses on the next generations of chips and systems, and on the enabling technologies for ambient intelligence. IMEC’s research bridges the gap between fundamental research at universities and technology development in industry. Its unique balance of processing and system know-how, intellectual property portfolio, state-of-the-art infrastructure and its strong network of companies, universities and research institutes worldwide position IMEC as a key partner for shaping technologies for future systems. IMEC vzw is headquartered in Leuven, Belgium, has a sister company in the Netherlands, IMEC-NL, concentrating on wireless autonomous transducer solutions, and has representatives in the US, China and Japan. Its staff of more than 1600 people includes more than 500 industrial residents and guest researchers. In 2007, its revenue (P&L) is estimated at about EUR 235 million. Further information on IMEC can be found on <!– document.writeln(” www.imec.be. 
 

Comments (1)

Fact 14 – California Drug Pedigree – Inference

February 13, 2008 at 4:38 pm · Filed under California e-Pedigree, compliance packaging, packaging line ·Tagged , , ,

The concept of “Inference” has been introduced into the drug serialization and ePedigree community.

What is ”inference” and how does it pertain to the compliance ?

“Inference” is a managed risk business process, not a regulatory process. A regulatory or enforcement body can not effectively legislate, monitor or regulate “inference.”

Let’s explore inference from a practical perspective. Inference is related to confidence.

I am going to put 48 bottles of serialized drugs in a case. Once I seal the case, I am going to infer the serial numbers are intact unless there is evidence the seal has been breached. That is a ’sound’ inference.

Let’s assume, I take the case of 48 bottles and I leave it on a shipping dock for a week, or I give it to a trucking company that takes 3 weeks to get the case 300 miles away. Inference may not be a good practice. There are too many points of vulnerability to confidently use inference.

Another scenario is that the original case has been opened at least once and ‘re-sealed.’ Not a good inference scenario.

Now, let’s move further down the supply chain. The original cases are opened at the wholesaler or retailer and they begin to building ‘totes’ with mixed product.  At this point, the inference is that all 48 bottles from the manufacturer are correctly serialized and as the drugs are inserted into the ‘mixed tote’ the wholesaler/retailer data captures the serial number on the item level.

This is called ‘picking.’

We know there are mistakes in picking.  Most companies have audits to catch mistakes.

The point that should be derived is that we have a pre-existing set of business rules in every organization that pre-defines financial risk associated with inventory shrink resulting from picking errors. Serialization does not change the risk formula, but serialization should reduce the errors.

Here is a picking scenario.

Today, an order from retailer location ‘111′ is for 4 bottles of item ‘123456.’ Modern distribution centers use some sort of data capture such as barcode (UPC) to ensure a high rate of accuracy by picking to the UPC rather than a name or a brand.

Now it’s not too practical to have picking of item level drugs to a specific serial number. That would require a human or a machine to sort through 48 bottles to find the unique serial number to pick, but it is practical to ensure the picking “system” contains the range of serial numbers for the specific drug that is acceptable to pick.

Once a case is opened for item level picking, the order picking system immediately creates a ‘data bucket’ of the 48 item level serial numbers and any quantity of pick must be validated against the range of 48 serial numbers.

There is basically no inference.

Now comes the ”tote.”

There is a tote with mixed product. As items are picked to the tote, it is presumed or inferred the product remains in the tote. Therefore there is an element of inference. Until the mixed tote is sealed there is always the possibility that an item can be removed or replaced, but this is relative to the security measures in place.

If this is an event that occurs at an unacceptable frequency, there various tools available to identify anomalies.  One tool is the broadening of CCTV capture stamped to time and location, as well as in-line scales to detect weight variations.

But there is no state of perfection where there isn’t some level of inference, but this inference is a business practice and risk event and not a legislative event.

In many respects the board oversteps it’s role when it entertains “inference.”

Assume the NTSB or the FAA agrees to some definition of inference of parts installed on an aircraft in association to an aircraft identifier.

Would you like to be on the aircraft that is missing a part when it left the factory because of an acceptable inference ? 

Now, if the airline removes a part, and doesn’t replace the part on the aircraft, that is a business practice and risk event. If the maintenance logs are not maintained accurately, that’s a business and risk event.

Below is the definition supplied by the California Board of Pharmacy:

“Inference” is a term used by some in the industry and by the board to refer to a vaied category of possible practices with regard to (temporarily) substituting aggregate-level (e.g., pallet, case, tote) tracking and validation for item-level tracking and validation, based on the limitations of, particularly, non-line-of-sight tracking technologies, and of distribution system partners.

The working definition of “inference” as it applies to serialization employed by the board is that it refers to the ability to “infer,” based on tracking and validation of a unique identifier attached to an aggregate package (e.g., pallet, case, tote) which has a hierarchical relationship with unique identifiers attached to each of the items/packages contained within the aggregate package – when appropriately combined with circumstances engendering confidence that an aggregate package identifier – that the items/packages within the aggregate package are what they are represented to be on the pedigree data, without individually validating (e.g., scanning) each item/package (immediately).

“Inference” does not appear in the pedigree law, and the the law does not presently permit the use of or reliance on “inference” in place of required item-level tracking or validation of pedigree data. However, the board has stated a willingness to hear input from industry regarding a perceived need for or possibility of “inference,” and has dedicated time during the E-Pedigree Workgroup meeting(s) to “inference.”

The board is exploring, and is interested in hearing from industry, whether and/or to what extent these are real or perceived issues to be addressed regarding “inference,” what solution(s) to these issues might exist or might be created, and whether these solutions would require some statutory change, promulgation of rules, or are a matter of enforcement discretion.

Leave a Comment

Fact 13 – California Drug Pedigree – Selecting datamatrix printing

February 13, 2008 at 3:59 pm · Filed under California e-Pedigree, compliance packaging, packaging line ·Tagged , ,

Selecting datamatrix printing is probably the most simple part of serialization selection.

Every drug producer is already using ink jet or laser printing for batch, lot and date code.

The same printers will be used to print the datamatrix or RSS code.

The clear leader is VideoJet.

VideoJet is a Danaher Company.

More important than printing is the QC of audit and verification of barcode quality. There are a handful of companies that produce off-the-shelf barcode verifiers.

Have a comment or an experience with datamatrix printing ? Write us by commenting. 

Leave a Comment

Fact 12: California Drug Pedigree – “Compliance packaging”

February 12, 2008 at 10:20 am · Filed under California e-Pedigree, FDA, compliance packaging, packaging line ·Tagged , ,

“Compliance Packaging” will be the key to meeting the January 2009 California pedigree deadline. 

 For California Pedigree compliance there are 3 terms that are important to remember:

- Contract packaging

- Re-packaging

-  Compliance packaging

Generally, contract packaging is a service provided by a third party to a drug company. Drug firms outsourcing packaging look to contract packagers to optimize the supply chain costs and help quickly deliver finished product into the marketplace.

To meet these requirements, wholesalers and contract packagers have expanded services well  beyond traditional services such as material selection and testing, and component assembly. Some contract packagers have evolved to turnkey packagers. In these partnerships, contract packagers often manage supply chain resources, purchase packaging materials, and manage finished inventory to ensure just-in-time delivery.

Re-packaging, is the function where a drug is re-branded. This is where the packager takes an existing branded or generic drug and either re-brands it as a private label, or constructs a kit containing a branded drug.

Both contract packagers and re-packagers operate under FDA guidelines, although the guidelines may differ. 

With the California Pedigree requirements, there is a new role in packaging…“Compliance Packaging.” 

For California Pedigree, those drug companies that invested in pedigree applications and serialization pilot lines have been focused on conversion of their packaging line to serialize 100% of their US destined production.

In reality, for every bottle of drugs that is required to be compliant with California SB1307 and SB1476, 9 other bottles on the same packaging line are serialized, even though they are destined to States that do not mandate item level serialization.

Now enters a new opportunity for contract packagers and wholesalers, to become “Compliance Packagers.” 

Imagine for a moment that a contract packager has a 200,000 square foot building in Reno, Nevada.  In the building, the contract packager invests in a serialization packaging line specifically for a drug manufacturer. Let’s call it ‘ABC Drugs.’

ABC Drugs, takes 6-9% of their production output and ships it to the “Compliance Packager.”  The Compliance packager opens the cases on the dedicated serialization packaging line, takes out the bottles, applies serial numbers to the bottles using datamatrix, or RFID, and returns the bottles to the same case. The case is serialized. Now the case is 100% compliant with California item serialization.

This “Compliance Packaging” is actually outside the FDA packaging guidelines. In many respects there is no difference between the process, as it relates to the FDA, than the services offered by a transportation company.

Who are the biggest potential winners in the role of “compliance packagers” ?

- Cardinal 

- Abbott

- Baxter 

- McKesson

- Amerisource

In addition, the majority of large drug manufacturers offer contract packaging to smaller drug producers. 

For the top 20 drug producers, 2 or 3 compliance packaging lines will meet the California Pedigree requirements.

For the next 50 drug companies, in size, 1 compliance packaging line will be more than adequate.  

 The capital investment, installed, is approximately $150,000 per line, for the first line, and $75,000 for subsequent lines. This is a turnkey line with conveyors, in-line printers, label applicator, CCTV security, vision cameras, RFID readers, accumulators and a turnkey software solution.

A 5 line shop, turnkey hardware and software, is $450,000. 

A single line can output 800 cases in an 8 hour shift. The ROI is 90-120 days after depreciation. 

Are we experiencing a new pharma business category, the “compliance packager” ?

If you’d like to find ”Compliance Packagers”, or you’d like to simply get support with an RFP, simply comment on the blog. (Tell us if you want to be unpublished and your comment will not be posted). 
 

Leave a Comment

Fact 11 – California Pedigree – Selecting RFID

February 11, 2008 at 11:31 am · Filed under California e-Pedigree, packaging line ·Tagged , , , ,

When selecting RFID, there are three primary factors:

- Rate (speed)

- Range (distance)

- Density

Packaging line:

Drug manufacturers need ‘Rate’. The packaging line needs to read/write RFID labels at a high speed. This activity occurs when the labels are spooled and the distance between labels is negligible, or the bottles/boxes as they travel 100-200 per minute down a belt with only 3-4 inches between the items.

Generally HF has a challenge in high speed. There are various claims of performance, and each drug company should define their Service Level Agreement to achieve the desired ‘Rate’ with their RFID packaging vendor, but overall ‘Rate’ is generally lower with HF than UHF.

Supply Chain:

Once the bottles/boxes are packed in shipping cases, ‘Rate’ is much less important and ‘Range’ plus ‘Density’ becomes more critical. Once you have 24-48 bottles (boxes) in a shipping case, the RFID antenna for HF need to be fairly close to the RFID labels to read all the HF labels in the case. UHF is much more friendly for ‘Range’.

For ‘Range’ HF is good up to about 4-6 inches with a mean of 5 inches from the antenna surface, but ‘Density’ performance suffers.

At the wholesaler, ‘Range’ and ‘Density’ is critical. This is why if you want to verify and validate all the case labels on a pallet, you need UHF on the cases, and this is where ‘Range’ and ‘Density’ become critical.

There is no way you can read 100% of the case labels on a pallet with HF. If you want to use RFID, there is no choice but to use UHF. On the other hand, if you don’t care to read all case labels on a pallet than it’s much less expensive to just use datamatrix or RSS barcode. Line -of-sight, is ‘line-of-sight’.  If you need to read cases at a few inch distance, save the money and use barcode.

The wholesaler opens the cases and the product is picked in individual quantities,  ‘Rate’ becomes a non-issue. Basically, items are read either in single quantities, or limited quantities.  Either HF or UHF will perform on the item level.  ‘Range’ is a factor. If you want accuracy, the HF environment will prevent cross-reads from other product. the limitation of ‘Range’ precludes false reads. UHF, regardless of the individual tag producer, will have cross-reads and produce errors in Pedigrees.

The optimal data carrier for picking and Pedigree accuracy is the barcode. The barcode may not be as fast to read as RFID, but the question has to be, “What’s more important at the item level picking operation for the production of a Pedigree ?  Speed or accuracy ?”

Drug Store:

At the drug store the same issues prevail as the item picking operation. Cross reads at the shelf and counter is critical. The technology with the least influence of cross reads is barcode. HF RFID produces a lower risk of cross reads on the shelf or counter. So once again the priority for Pedigree is, “What’s more important at the item level picking operation for the production of a Pedigree ?  Speed or accuracy ?”

Leave a Comment

Fact 7 – California drug pedigree

February 6, 2008 at 2:29 pm · Filed under California e-Pedigree, packaging line ·Tagged , ,

Question:  Does 100% of the production of a prescription drug need to comply with January 2009 California ePedigree requirements ?

No -

Answer: Only the product shipped to be consumed in California is required to have a pedigree ?  Generally it’s limited to approximately 10% of US sales.

Do you have a question ? Post a comment. 

Leave a Comment

Fact 6 – California drug pedigree

February 5, 2008 at 9:19 pm · Filed under California e-Pedigree, packaging line ·Tagged , , , , ,

The transactional cost of printing a human readable unique ID # on a prescription drug container, or case, is less than 1 penny per transaction.

A case containing 12 items cost less than 1 penny to print a serial number.

A case containing 24 items cost less than 1 penny to print a serial number.

A case containing 48 items cost less than 1 penny to print a serial number.

Printing a serial number on the container before the packaging line will relatively not add to the cost of packaging.

Printing a serial number on the label(s) before the packaging line will relatively not add to the cost of packaging.

Printing a serial number in the packaging line requires an inline printer costing between $5,000 - $10,000.  The cost of the printer amortized a year of printing is less than 1 penny per item. 

Comments (1)

Fact 5 – California drug pedigree

February 1, 2008 at 8:41 pm · Filed under California e-Pedigree, packaging line ·Tagged , , , , , ,

Daily consumption of ‘branded’ prescription drugs in California for each individual drug, by case quanitity:

Top 10 branded prescription drugs – 160 cases/day/drug

Top 11-20 branded prescription drugs – 90 cases/day/drug

Top 21-30 branded prescription drugs – 40 cases/day/drug

Top 31-50 branded prescription drugs – 20 cases/day/drug

Top 51-100 branded prescription drugs – 10 cases/day/drug

Top 101-200 branded prescription drugs – 5 cases/day/drug

Generic drugs

Top 10 generic prescription drugs – 40 cases/day/drug

Top 11-20 generic prescription drugs – 20 cases/day/drug

Top 21-50 generic prescription drugs – 10 cases/day/drug

Top 51-100 generic prescription drugs – 5 cases/day/drug

Leave a Comment

Fact 4 – California drug pedigree

February 1, 2008 at 3:15 pm · Filed under California e-Pedigree, packaging line ·Tagged , , , , ,

Excluding registered domestic manufacturing sites of medical gases, as of 2004 there are 3300 domestic drug manufacturing sites and 2700 foreign facilities registered with the FDA.

Over 90 % of the registered sites produce prescription drugs in bulk for downstream dispensing packaging.

320 domestic drug manufacturig sites produce dispensing packaging and 190 foreign facilities produce drugs in dispensing packaging.

Dispensing packaging is defined as packaging that is properly labeled to be shipped to a pharmacy, hospital, clinic or physician.

Leave a Comment

Fact 2 – California drug pedigree

January 31, 2008 at 8:31 pm · Filed under California e-Pedigree, packaging line ·Tagged , , , , , ,

The cost of a 4in. x 6in. case label ranges from $.03 to $.11 each label.Adding a datamtrix serial number to a pre-existing case label does ‘not’ increase the label cost.

Adding RFID serial number to a pre-existing case label adds $.08 – $.12 per case label.

If a drug packaging line produces 40,000 cases a year, of which 4,000 cases are destined for California, the added annual cost is as follows:

- Current case labels for California = 4,000 cases x (Avg.) $.07 = $280.00/year

- Case labels with datamtrix (2D) for CA = 4,000 cases x (Avg.) $.07 = $280.00/year

- Case labels with 2D and RFID for CA = 4,000 cases x (Avg.) $.15 = $600.00/year

Industry-wide, approximately 3 million cases of prescription drugs are shipped into California, or produced in California, for California consumption, annually.

Leave a Comment

Older Posts »