Single Use-Technology Topics Identified by Participants as Already Covered by Organizational Activities
| Topic | Activity |
|---|---|
| Integrity Verification or Leak Detection | BPSA is developing a proposal |
| Particles Methods | BPSA is developing a Publication |
| Integrity Methods | BPSA is developing a proposal |
| Extractables Testing | BPOG has developed a Extractables Testing Protocol and has submitted it to ASTM, ASME-BPE, BPSA, and other organizations |
| Leachables Testing | BPOG future work stream |
| Comparability of Supplier Extractable Data | BPOG Protocol |
| Interchangeability of Materials or Components | Discussed in PDA Technical Report No. 66, 2014 |
| Supplier Quality System and Regulatory requirements | Discussed in PDA Technical Report No. 66, 2014 |
| Use of Supplier Documentation and Verification Practices | Discussed in PDA Technical Report No 66, 2014 |
| Standard Design SUS vs Custom Design SUS | |
| Supplier Qualification | Discussed in PDA Technical Report No. 66, 2014 |
| Sterility | Discussed in PDA Technical Report No. 66, 2014 |
| Material and Supplier Qualification | Discussed in PDA Technical Report No. 66, 2014 |
| Operator Training | Discussed in PDA Technical Report No. 66, 2014 |
| Process Leachables | Discussed in PDA Technical Report No. 66, 2014 |
| Supplier Quality Agreement | BPSA is developing a quality agreement template for suppliers |
| Risk Management of SUS | Discussed in PDA Technical Report No. 66, 2014 |
| SUS Handling and Leak Prevention | Discussed in PDA Technical Report No. 66, 2014 |
| Supply Chain Management | Discussed in PDA Technical Report No. 66, 2014 |