Laboratory Clean Room Facility and Guidelines: CelluGen clean room laboratory with temperature controlled centrifugation based ElixCell PRP – Forte follows proprietary processes technology with qualified staff and stringent quality control protocols.
Processing Facility – Processing, activation and injection preparation of PRP – Forte is performed in clean room conditions environment (class 100 to class 1000).
Sterility Analysis for Screening Microbial Contamination – The peripheral blood taken from the patient is analyzed for Microorganisms contamination for the presence of aerobic, anaerobic and fungal microbial contamination.
Infectious Disease Screening – The peripheral blood sample drawn from the patient is screened for rapid infectious disease screening including Anti HIV (TRI DOT), Anti HBc and Anti HCV. The Infectious diseases screening are done to doubly make sure the patient is sero negative for these common infectious diseases.
PRP – Forte – The peripheral blood drawn from the patient is checked for complete and differential blood count pre and post processing of PRP – Forte with emphasize on platelets count.
Imported Equipments for Separation – After blood is taken from the patient’s vein, the platelet is separated from whole blood using imported specially designed equipment with controlled speed and temperature centrifuge under highly sterile conditions using Bio safety cabinet.
The pH of ElixCell PRP – Forte is greater than 6.2 and lies within international guideline range between 6.2 – 7.4 aiding in higher platelet aggregation and recovery.
Low Leukocytes count in ElixCell PRP – Forte helps in optimal efficacy (contributes to inflammatory cytokine production. Therefore, leukocyte-reduced PRP – Forte may be the optimum preparation to stimulate superior healing without scar tissue formation.
Low RBC Count in ElixCell PRP – Forte ensures high purity.
The Certificate of Analysis (CoA) provided with ElixCell PRP – Forte released for therapeutic application includes pre and post processing evaluation of
- Platelet Count
- WBC Count
- RBC Count
- Hematocrit count
- Mean Platelet value
- To produce ElixCell PRP – Forte an average of 32 ml of peripheral blood is collected in ACD –A vacutainers
- Blood Sample collection is done from patient’s location
- Final Product:
ElixCell PRP – Forte
Volume 4mL ( 5-7 X from baseline)
Ready to use end product delivered to clinic at the time of application
End product to be utilized within 4 hours of preparation