The Project: A company required molded components that would come in contact with pharmaceutical processes and needed to minimize the risk of contamination.
The Solution: Animal derived component free resins were utilized and molded in a newly created cleanroom.
As an engineering-driven custom molding/assembly company, Advanced Molding Technologies LLC welcomes new challenges. In 2009, the company was in discussions with an existing customer about a new family of products. This new family of products resided in the life science industry and would have contact with pharmaceutical and biopharmaceutical processes.
In addition to the typical latex free, Bisphenol-A free, Phthalate free, and USP Class VI designations, the molded part designs called for use of animal derived component free (ADCF) resins. As the name suggests, ADCF describes resin that is manufactured with no animal derived ingredients, the most common being release agents derived from bovine tallow. ADCF also requires that the resin/molded component not come in contact with any non-ADCF plastic items such as bags, hoses, and tubs.
Historically, the customer had to wash purchased molded components prior to their use in downstream processes. This wash was necessary to remove any possibility for contamination of the parts, including native particulate. Given the risks and costs involved in washing the parts in-house, the customer had also added a “no wash” requirement to the part designs. To eliminate the prerequisite of washing the parts, the products would also need to meet stringent bioburden and subvisible particulate requirements.
A supplier to the global medical market, Advanced Molding Technologies LLC fully accepted these requirements and had mature systems in place to meet them. The challenge, in simple terms, came down to maintaining the integrity and cleanliness of the raw materials and molded components throughout the entire manufacturing process.
After a complete review of its processes, which involved everything from specifying purchasing requirements, through receiving of the finished goods at the customer level, several opportunities for risk reduction were identified. Actions were taken to remove or minimize risk in all of the identified areas. In addition to strengthening all aspects of material identification and handling, Advanced Molding Technologies LLC went one step further and constructed a custom, dedicated cleanroom environment. The work cell was assembled using molding equipment, cleanroom air flow, and part handling equipment designed to mold, handle, and package parts with minimal exposure of the molding environment to human operators.
The new manufacturing processes were challenged and tested in accordance with the qualification plan Advanced Molding Technologies LLC developed with its customer. The result was the implementation of an approved manufacturing process, meeting all requirements, with appropriate monitoring systems established to verify the process. The ADCF cleanroom environment continues to produce product according to plan, making Advanced Molding Technologies one of the few companies able to produce ADCF certified parts today.
Advanced Molding Technologies LLC is now in the process of investigating RNase- and DNase-free molding.