Adhering to strict procedures and quality standards to protect against contamination is a never-ending job in the pharmaceutical industry. It requires discipline and attention to detail during every step of the process from manufacturing to packing, handling and transportation.
If your pharmaceutical facility uses FIBC bulk bags to store, transport, or handle materials, then you need a supplier that understands your challenges and high quality expectations. Below are some things to look out for when evaluating a supplier.
BRC Facilities are Key
The standards applied to the pharmaceutical industry are generally the same as those applied to the food industry. With regards to your supplier, look for certifications and the capability to produce packaging up to the following standards:
- ISO 9001:2008
- ISO 22000:2005
- AIB International
- BRC Global Standards that meet GFSI standards (GFSI stands for Global Food Safety Initiative)
One standard to highlight is BRC certification. You’ll want to make sure that your supplier is sourcing from a manufacturer that has third party certifications like BRC. These standards and certifications ensure that the bags meet specific criteria critical to producing a bulk bag that is safe for pharmaceutical use. BRC Manufacturing standards include:
- Proper ventilation
- Pest control procedures
- Metal detection
- Light table inspection
- Proper personnel wardrobe
- Proper personnel hygiene
- HACCP (Hazard Analysis and Critical Control Points) Program
- Record keeping
100% virgin resin is one of the most critical components of a pharmaceutical bag. Standard bags often use recycled resin during the bag coating process. This can result in contaminates in the bag’s coating making it unfit for use in the pharmaceutical industry. When purchasing bags for pharmaceutical use, make sure your supplier’s bags use 100% virgin resin.
The Importance of FIBC Liners
FIBCs for pharmaceutical use are often paired with a polyethylene liner because of the fine, powdered nature of the product. The benefits of polyethylene liners include:
- Extra layer of protection for materials
- Keeps outside moisture and contaminates out
- Provides better containment for powders
Polyethylene liners can be purchased separately and inserted manually into each bag, or they can come pre-inserted into each bag for ease of handling. Remember to ask your supplier about the availability of poly liners when purchasing your bag.
The Dangers of Static Electricity
The flow of finely powdered substances can cause a dangerous buildup of static electricity when bags are filled or discharged. This is especially relevant in the pharmaceutical industry where transporting powders in FIBCs is a common occurrence and materials are often volatile. Properly mitigating the dangers associated with the buildup of static electricity can help you avoid a potentially catastrophic event.
There are four specific types of bags (A, B, C, and D) each with unique features and safe uses. Types B-D are specifically equipped with features that help mitigate the build up of static. When purchasing bags, be sure that your supplier is educated on types B-D and be sure to have a conversation about what type is best for your application.
To learn more about the different types of bags and static, check out this article.
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Finding the right bulk bag polyethylene liner for your product and application can be difficult. Not only is it important to determine the right type of liner for your product and application, it is imperative that you also determine the correct size of liner for the specific bag you are using.
To accurately determine what size polyethylene liner is right for the bag you are using or are interested in, download our FIBC Bulk Bag Liner Estimation Calculator by click the button below!