Rigid bioprocess container are often used for drug substance storage, to reduce risk of loss through breakage when the drug is of high value. Plastic bottles and carboys are frequently chosen because they offer clarity for inspection and are available as single-use items. Many of these plastic containers were created for R&D and media applications where standards are more relaxed compared to the pharmaceutical manufacturing environment.
Common concerns with bottles used as bioprocess containers
- Particulate: How clean is the manufacturing process? Some “controlled environments” used in manufacturing are enclosed, but not controlled to a recognized standard! Furthermore molding processes that require trimming contribute particulate.
- Inclusions: Black, brown and clear inclusions are often found in container walls. Is your company one of those performing 100% inspections of bioprocess bottles to remove numerous containers with inclusions and other defects?
- Bad seals: Some containers exhibit high cap seal failure in the range of 10-20%. How can this be allowed to continue?
- Limited traceability: Ideally containers should have on-bottle identity including batch number and expiration date so the container is easily traced to the manufacturer’s certificate of compliance and their batch records.
The source of these problems often lies in the method of manufacture, but also in the manufacturing personnel and environment. In many instances the manufacturing process was set up decades ago and has not evolved. The molding equipment simply does not produce containers to the standards required by pharmaceutical manufacturing.
Some manufacturers use temporary workers in their molding operations. How well are these trained? Are they expected to know multiple quality standards? Most molders utilize their equipment for a number of different products with multiple quality requirements.
PharmaTainer™ products; designed to address all these issues.
- The molding facility was new in 2011 and built to maintain cleanliness. The entire molding area is a clean area with sealed floor and surfaces.
- Molding machines use HEPA filtered air and are enclosed to maintain an ISO Class 5 environment. Injection blow molding
technology produces containers that require no trimming while producing precision formed necks for reliable sealing. Containers are low particulate and low bioburden without any post-molding cleaning.
- Capped bottles are packaged in an ISO Class 7 area. The inner pack is a vacuum pack; the presence of vacuum at the point of use is assurance package integrity and sterility.
- The double-seal closure system provides consistent reliable sealing, tested to -80°C.
- Traceability includes on-bottle batch number, expiration date and a serial number for each bottle. Each layer of packaging is also labeled with product identity, batch number and expiration date.
- The manufacturer, Cellon SA, does not employ temporary workers. Personnel are trained to a single quality standard designed to meet the requirements of today’s pharmaceutical manufacturing environment.
If you are experiencing the problems described in the first part of this article, look to PharmaTainer products as the cure for these ills!
™PharmaTainer is a trademark of Cellon SA, Bascharage 4940 Luxembourg