The GIBCO® Evolution - An FAQ

1.   Why is the bottle shape changing?
 
We’ve redesigned the bottle to improve our customers’ workflow, increase room for supplementation and improve handling and storage.


2.   Do we have to switch to the new bottle?

All GIBCO® catalog and custom products in 100mL, 500mL and 1000mL  are transitioning to the new bottle in the 4th quarter of 2008. Is there some reason why you would not want to switch to this new bottle?

3.   With the change in cap material, what is the impact on the products?

The cap material is changing to HDPE – a material commonly found in other cell culture products – Corning roller bottles and Nalge bottles, for example.  We do not expect, nor have we seen any impact to date. The closure has been designated as a Class VI material per USP <88>.  Furthermore, there has been no impact on shelf-life & stability for DMEM (11965) and FBS (26140) for 12 months. (These were initiated in March of 2007 prior to a market research study conducted last spring).

 
4.   I am not sure how the shape change could impact my use of the product, can we get a sample or see some photos of the new bottle?

We can provide you with a sample through your account manager or you can request a sample through our website. 

5.   When will we begin to see the new bottles?

Catalog products will begin to enter the market in the fourth quarter of this year - in the new bottle. You can expect a transition of several months depending on the SKU or if the product is on reserve.

6.   Does this mean there are changes to the formulations?

No! There is no change to the product formulation inside the bottle. All products are still manufactured at our GIBCO® production sites in Grand Island, NY; Paisley, Scotland and Auckland, New Zealand. 

7.   How is the label changing?

The product family colors introduced in 2006 will be maintained. There will be no change to the content of the labels, though there will be some format changes due to the new sizes of the labels. 

8.   Will there still be room for notes and a cap label?

Yes. The back label will still have room for annotation and the cap label will be maintained. 

9.   Are all Sera products going into the new bottles as well?

All sera products in 100mL, 500mL and 1000mL bottles will transition to the new bottle. 

10.  Will there be any impact on my cells or assays that use the products in the new bottle?

No. Neither the bottle resin is changing nor are the product formulations. We also have representative formulations on stability to ensure product comparability with the current bottle.

11.  Can I find out what products are on stability and specifically if my product is?

We can share with you our list of products (?) on stability. However, we do not put all products on stability – only representative formulations. 
 

12.  What is the impact of irradiation on the bottle?

The bottles have been tested for functional performance at the normal irradiation dose and an elevated irradiation dose to simulate the cumulative affect for virus inactivation.   All testing to date suggests that the bottles are not impacted by this process.

13.  Will the new bottle affect results of the gamma irradiation study done on sera products?

No the dose mapping study is not impacted by the change in bottle shape. We plan to do a dose mapping study with the new layout with the irradiator, but do not anticipate any changes to our original study.

14.  Can we freeze the bottles at -80ºC?

Our bottles are tested on dry ice (simulates -70ºC). Thus we cannot guarantee bottle performance at this temperature. We do not expect any problems, but the bottles may become more brittle due to that temperature and should be handled with care.

15.  Will the Drug Master Files that have been submitted to the U.S. FDA be updated to include the new bottle/cap?

Yes, this will be done in Q4 2008 and submitted to the FDA in Q1 2009.

16.  How do I mix or "swirl' with this new design?  It was so easy with the round bottles.

A dye study was done that showed when supplements were pipetted into the new bottle their overall flow was circular and provided good initial mixing.  Overall a gentle rocking back and forth – away from the cap – has proven the most effective.

17.  Can I pipette straight out of the bottle – thus making it easier to read the meniscus in the pipette?

Yes, the larger size of the mouth allows easy pipetting straight out of the bottle with out tipping.

18.  Can I buy a filter top for this bottle or is there a filter unit set with this new design?

We currently do not have this ancillary product available.  However, we are looking into the feasibility of developing this post launch.

19.  Can I buy the new GIBCO bottle empty?

We will offer the bottle for sale to end users and a SKU is being developed. We may not have this as an option until Q1 2009.

20.  Is there a greater chance of contamination in the bottle due to the larger mouth?

Laminar flow hoods are designed to minimize potential contamination, no matter what the size of the opening. Further to that, we will be completing a study that shows our new bottle to be equivalent to our previous round and competitors bottles.

21.  Does the increased headspace cause a shift in pH?

We have proven through 2 separate experiments that the increased headspace has no effect on product stability, including pH specification.

Real time shelf life stability on worst case product formulations prone to pH shifts and sera, met all product specifications.

A specific design of experiment was also performed to investigate potential issues w/ the headspace - again no impact on pH was seen.

22.  I see that this bottle has the recycling symbol on the bottom of your bottles. Can I recycle it?

The plastic is PET and can be recycled.  However, due to the nature of many of the products in the bottles, many institutions will not recycle them – due to potential biohazard issues.