Laboratory Clean Room Facility and Guidelines: CelluGen clean room laboratory with controlled centrifugation proprietary processes technology with qualified staff and stringent quality control protocols.
Processing Facility – Processing, activation and injection preparation is performed in clean room conditions environment (class 100 to class 1000).
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.
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 in Bio safety cabinet.
The pH of 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 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 PRP – Forte ensures high purity.
The Certificate of Analysis (COA)
The peripheral blood drawn from the patient is checked for complete differential blood count pre and post processing with emphasize on platelets count.
COA provided with 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 PROC / 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