There are a number of variables that make a definitive answer difficult. For a complete response, we need more information on process flow and your equipment and capacities. However, here is a qualified response.

First, identify the blister(s) after introduction into the cartoner (just prior to loading). Then, print an identification on the carton based upon the blister/blisters (we frequently use a 2-D bar code on the end flap of the carton). Finally, load the cartons into the case, read, and identify all bar codes (print and apply a label that is applied to the case that contains the carton identifications). The application will dictate what is printed (the identifier for each carton or a “License Plate” tag for the case).

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.

Key to integration is the experience of the supplier, the capability of the supplier’s staff for quality work, and the willingness of the supplier to stand behind challenges that may arise. There are trade offs in hiring a consultant versus charging the supplier of the most critical equipment (yes, it should typically be this supplier on the line) with your integration project.

Consultants that specialize in integration may have a wealth of expertise and experience to help you avoid pitfalls that others may not see. Everything from input and discharge heights, floor plan layout, logistics of material flow, and control are only a few of the issues to be covered. On the downside, it can seem costly to hire a consultant as its in addition to the cost of the equipment and facility modification. Also, the consultant will not have a mastery of any of the equipment on the line and will typically always rely on the suppliers to provide support.

The supplier of the most critical (often most expensive, too) piece of equipment will be naturally engaged in the success of the line and will typically have a broad general knowledge of the issues and challenges needing to be addressed. This is usually more cost effective than the consultant. But beware: many equipment suppliers will say they do integration. Be sure to ask for references for the size and relative scope of your project. Be sure on your end to have enough capable staff, time, and test product available to support the integration.

This response is from my colleague Don Sonntag, division manager at ProSys Innovative Packaging Equipment:

There are several options available for filling and closing a container with a dual-chamber pump (some options listed may not be feasible for all pump container styles):

1) Manual System - Single-Fill Head, Double Pass: designed for low production speeds (less than 20/minute) features manual container and closure loading, then semi-auto filling and closing Product A. System is then cleaned and changed over, pump containers are then run through a 2nd time for filling and closing Product B. This manual system requires multiple operator involvement but offers an economical entry-level cost and requires the pump container to be run through the system twice.

2) Manual System - Double-Fill Head, Single Pass: designed for low production speeds (less than 20/minute) features manual container and closure loading, then semi-auto filling and closing Product A then filling and closing Product B. This manual system also requires operator involvement but only requires the pump container to be run through the system once.

3) Automated System - Single-Fill Head, Double Pass: for moderate/high production speeds, features automated pump container and closure loading, filling and closing Product A. System is then cleaned and changed over, pump containers are then run through a 2nd time for filling and closing Product B. This style of automated system features less handling for the operator and automated feeding of the pump container and closure, but requires the pump container to be run through the system twice. System cost is based on production speeds and level of automation required.

4) Automated System - Double-Fill Head, Single Pass: for moderate/high production speeds, features automated pump container and closure loading, filling and closing Product A and filling and closing Product B. This style of automated system only requires the pump container to be run through the system once. System cost is based on production speeds and level of automation required.

Pumping: many options are available for feeding product to the fill stations from drums or bulk storage tanks. Actual pump system design is determined by storage type, product viscosity, and flow rates required by the filling machinery.

I do not know of an industry definition. It is really more about the application of Good Engineering Practices. Fail-Safe systems are one method of mitigating risks as determined from my earlier post.
Here are some examples:

a. Duplication of sensing.
b. Redundant sensing, different from above in that you use different methods of sensing.
c. Sensor checking to verify on - off each cycle.
d. Design the control system for fail to off (reject all).

The Risk Assessment described in my earlier post will determine which steps to follow.

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)