Quality Control:

We strive to demonstrate to our clients that we are firmly committed to the quality of our services through our employee’s dedication to customer satisfaction and fulfillment of personal objectives.

Panymex International abides by the principal of a stringent system of quality management focused on all members of the organisation by means of goal objectives embedded throughout that all have the customers’ needs in focus. Therefore, the continuous improvement is a permanent directive of the Group

Our quality policy is based on SOPs that establish regulations and directives in all the involved processes with the aim of obtaining an optimal degree of operatability and product excellence.

The SOPs are the following:

SOP # LP001: Hygiene Practices and Control (April 2006)
SOP # CAD001: FBS. Document Control (April 2006)
SOP # P001: Processing of Fetal Bovine Blood & Serum (April 2006)
SOP # AC001: FBS. Critical Deviations and Corrective Actions (April 2006)
SOP # CA001: Freezing and Storage of Fetal Bovine Serum (April 2006)
SOP # SP001: Sampling of Fetal Bovine Serum (April 2006)
SOP # AUD001: Auditing of Blood Collection sites (April 2006)
SOP # 4QC001: Quality Control of the Fetal Bovine Serum Production (April 2006)
SOP # PE001: Packing and Shipping Protocol for Fetal Bovine Serum (April 2006)
SOP # PS001: FBS. Training of the Personnel (April 2006)
SOP # DS001: Protocol of Management of the waste been used (April 2006)

The FBS produced by the Group is traceable throughout the process of collection, processing, packaging and export which at any time allows us to identify and document product data in terms of origin, date of production and general product information. Our ability to trace the product as described above is therefore integrated in the processes of production and administration throught the company and is an integral part of our after sales customer service.

Normal values of FBS:

The FBS produced by the Group is only exported after being rigorously examined by a control of basic quality tests that it include:

PRUEBA	VALORES
Determinación de bacterias totales	0 FCU/ml
Determinación de bacterias Gran Negativas	0 FCU/ml
Determinación de hongos	0 FCU/ml
Valores de proteinas totales	3.5 – 4.2 G/dl
Electroforesis de proteinas ( Optativa )
Niveles de hemoglobina	≤ 20 mg/dl
Osmolaridad ( Optativa )
Endotoxinas	≤ 10 EU/ml

Export documents:

All our lots are exported following international sanitary regulations and are safeguarded by the following export documents:
• Certificate of origin
• Disease status information
• Certificate of analysis signed by a veterinarian from country of origin
• Packing list
• Copy of the import permits from USDA