Ask yourself this: what is the annualized labor cost to do this manually? Most literature feeders (vacuum or friction styles) will cost less than one full-time person for one year. This means a payback of less than one year.

If this ongoing production requires literature, it’s pretty easy to justify automatic feeding. This will also improve quality because you can add automatic sensing to verify the placement. Several companies offer either friction feeders or vacuum feeders that can do this. My company offers both.

Thanks to Joerg Liedtke from Laetus GmbH for helping to respond to questions 1 and 2.

1. Trying to understand future requirements for Serialization on vial label
and outer carton for an IV product….?

A: Currently the smallest unit to be serialized is the “unit of sale.” Typically a single vial is not sold, so in your case, serialization would likely need to occur for the carton.

2. When will serialization be required by FDA (Federal) and/or by the state of California?

A: Basically the FDA is currently just starting to define an SNI, see more information at this link: http://www.fda.gov/RegulatoryInformation/Guidances/ucm125505.htm#_Toc254967078

The California State Board of Pharmacy enrolled a E-Pedigree law that will become effective in 2015.
Please find detailed information here:

http://www.pharmacy.ca.gov/about/e_pedigree.shtml

3. How can this be automated?

A combination of product handling, printing, vision, and IT is required for a complete solution. Firms such as Laetus can provide much of the solution while MGS Machine can provide product handling of the carton as seen here:

http://www.mgsmachine.com/prodvideo.php?id=25&vidid=video1

Factors that affect this decision are: (1) glue versus heat sealed wallet, (2) the pricing of your contract relative to the labor required, and (3) the length of the contract. First, a glue wallet is typically produced with automated machinery but heat seal can be done semiautomatically. If a glue wallet is required, so likely will be an automated solution regardless of line speed. Pricing, labor cost, and length of contract are all related. A simple assumption of $40K annualized cost per line operator with a two shift operation is $80K annualized per operator position, which is potentially reduced by automating. With only reducing the line by a handful of operators, via automation, your payback can be as little as one year. This also goes to the length of the contract. If you can get at least an 18-month or two-year contract (or longer), then its likely that you will benefit from automating your line. Also, once the job is finished, you’ll own the asset and can sell time on it for new projects. Feel free to contact me directly with your particular scenario.

It is common that new, added technology requires staffing changes. Local two-year technical schools can be a good source of these types of people. In our current job market, some good people are “on the bench,”
so now is a time to hire. The other key issue is how to keep current manual labor productive when knowing their jobs will be eliminated? Best situation is when you’re adding automation to expand your business and
absorb those staff into new roles. This eliminates the threat of job loss weighing on current staff.

Frankly, it’s more difficult if you are intending to reduce staff as the objective. No easy answers, but probably keep the changes under wraps as long as possible and perhaps plan a “soft landing” of some sort such as outplacement or small severance. That might ensure that you’ll get their cooperation until the changes are complete.

Follow GAMP 5, which is a Risk-Based Approach to Quality.

a. First you need to identify the functions that have an impact on Patient Safety, Product Quality, and Data Integrity. Your company policy should dictate the acceptable level of risk for each. The aforementioned items will need to be mitigated until an acceptable risk level is reached. Validation will subject these to a higher level of testing. One example of this is a bar code identification system.

b. Items not listed above can be subjected to Good Practice and can undergo Basic Testing at Commissioning. One example of this is a low-level sensor for a carton magazine on a cartoner.

c. A great source for reference material is at http://www.ispe.org/cs/jett/gamp_americas_jett_sample_docs. Download the document JETT Risk-Based Approach to Automated Equipment R01

Often package volume doesn’t justify full automation. In some cases, we’ve automated part of the process and left other processes manual. In a few select instances, we’ve provided complete, fully automatic packaging lines. A reputable equipment supplier can help you determine the level of automation based on your specific project.  Some considerations:

a. Your volume, does it justify the investment?

b. The number of changeovers?

b. Labor savings? (Labeling verification requires two inspections if done manually.)

d. Workers comp issues?

e. Quality issues (equipment should improve accuracy)