Biomanufacturing companies report 10-25% of sterile, “ready-to-use” mini-bulk containers are rejected yearly. Common sense and
cGMP dictates that these problems be remedied. They can be. Testing, processes and technology are available to ensure containers meet the grade. But quality control, regulatory, technological and, big shocker, money reasons, prevent changes needed to correct these problems.
Although containers are rejected for many reasons, the following are the biggies. Top Reasons for Container Rejection
- Failure to seal
- Holes, from hard-to-spot pin-sized to finger sized
- Missing closures
- Mis-labeling (e.g. missing radiation dots)
- Particulate (e.g. bits of plastic, dirt or scarier yet, “unidentified” material found adhered to cap liners)
- Packaging (e.g. unsealed primary packaging and/or shrink wrapping holes)
In fact if David Letterman could do a top 8 ridiculous supplier responses (5 just wasn’t enough) to biopharma container problems it might read:
“Top 8 Supplier Responses to Container Problems”
8. Supplier’s actual QC hole rule #1: individual holes in [primary pack] are acceptable if they don’t exceed ¼”.
7. Supplier’s actual QC hole rule #2: individual holes in [primary pack] measuring ¼” (6mm) acceptable up to 3 occurrences per pack.
6. Actual supplier QC hole rule #3: Multiple holes in [primary pack] less than ¼” are completely acceptable!
5. Holes? The pressure-decay leak detector is set for speed, but it still finds the really big ones!
4. Operator/packers pack containers with obvious defects, but “Hey I just pack‘em. I’m not QC!
3. Think that container hole is big? I can fit a finger through this one!
2. Is that sweater fuzz I see on that cap liner?
And the top, and actual, not-made-up response to container problems is:
1. Top biopharma manufacturer tells major CMO that the container sealing problems “could not be fixed”.
Well isn’t that just a “have a nice day” for you?
So why does the biopharma industry continue to baulk at change, accepting so many substandard containers? Two words. Money and regulation.
Money & Regulation – Roadblocks to Mini-Bulk Container Nirvana
Historically, there have been few sterile, ready-to-use container suppliers. Moreover, as regulatory requirements for single use disposables evolved, many mini-bulk containers considered “state of the art” 20 years ago have failed to keep pace with industry standards. Money and fear of increased regulatory scrutiny incurred by a DMF revision cause pharma to resist change. Many simply tolerate the norm, the path of least resistance.
So while pharma complains, they continue to buy low quality containers. And container manufacturers are content to produce lackluster product as long as customers continue to buy. In fact, many manufacturers are motivated to maintain the status quo. If sales are satisfactory, why invest the time and money in technology to attain higher quality levels? And then there’s that customer notification problem, “If we tell them we’re making big changes, they’ll have to re-validate and there’s a risk we could lose the business.” Indeed, they might choose to validate a better product!
How Do We Fix the Mini-Bulk Container Problem?
Just say “no” to low quality containers. Say “yes” to:
- containers that meet current pharma standards,
- manufacturers that are 100% committed to producing clean, sterile products for biomanufacturing and
- manufacturers with highly trained personnel who take pride in producing best-in-class containers.
Experience a company, Cellon SA, which has built a molding facility solely to meet current pharmaceutical standards. Their molding technology is state-of-the-art, allowing certifications of containers to USP <788>. Every container is visually inspected for defects before vacuum sealing the primary pack. The vacuum seal tells you the sterility barrier is intact. On-bottle labeling sets a new standard with batch number, serial number and a machine-readable code to maximize traceability and simplify your inventory handling. Cellon provides a significant documentation package for the PharmaTainer line and continues to add to it. Common sense prevail; we just have to be open to change.
Learn more about the best sterile bottles and carboys for storage of biologics. View our slide show “PharmaTainers – a Slide Show Tour” at http: /downloads/literature
About Jon West: Single-use containers have been my professional focus for 20 years. I know the physical and documentation requirements for best-in-class, in-process containers. I understand the problems that result when containers don’t meet expectations. Biofluid Focus and part of my mission to educate industry professionals about containers while providing the highest quality single-use containers that meet current standards.
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