Synthesis and Processing of PEEK for Surgical Implants - PEEK Biomaterials - page 14

(A)

(B)

Figure 2.3 Clean room production environment for MG
PEEK. Photo courtesy of Invibio.

Enhanced Quality Control procedures and stan-
dards, together with extensive testing and product
release control, ensure a tight product specification for
PEEK-OPTIMA. Test results are verified by dual
testing at an independent UKAS-accredited labora-
tory. Invibio has a “no-change” agreement for the long-
term supply of PEEK-OPTIMA biomaterials to assure
its specification and production methods over time.

(C)

2.5 Processing of Medical Grade
PEEK

Despite the exceptional properties of medical
grade PEEK polymers, these materials are processed
by traditional plastic processing methods ( Table 2.3 ).
medical grade PEEK-based materials exhibit melting
temperatures of around 340 C; however, PEEK
polymers demonstrate good melt stability and remain
workable with most conventional process equipment
between 360 and 400 C. Commercial manufacturers
of implantable grade PEEK provide detailed guid-
ance and support for all processing techniques.
However, for students and researchers, a brief
summary of the main techniques is discussed in the

Figure 2.2 High-resolution optical micrographs of
PEEK-OPTIMA LT1 granules (A, B) and representative
scanning electron micrograph (C). SEM image courtesy
of Josa Hanzlik, Drexel University.

the manufacture of PEEK-OPTIMA biomaterials,
including clean room conditions for processing
( Fig. 2.3 ). Process documentation is archived to
provide long-term batch and rawmaterial traceability.