Facilities

CHALLA LABORATORIOS

Has a plot of 500 m² and with a construction equivalent to
1,500 m² distributed over 3 levels.

Low Level

  • Secondary conditioning
  • Warehouse of raw materials, container and packaging material
  • Warehouse of finished product

1st Level

  • Production Area
  • Primary conditioning Area

2nd Level:

  • Physical-chemistry and microbiology laboratories
  • Administrative areas

Design and construction according to compliance for the manufacture of pharmaceutical products

The lighting, temperature, relative humidity and ventilation are adequate for the activities carried out within a laboratory.
The entry of personnel to the facilities is controlled according to the activities carried out.
The design and location of the areas has a flow of personnel, supplies, product in process, finished product and waste that is carried out in a logical, sequential and
unidirectional order.

LABORATORIES

Physical-chemistry and microbiology laboratories have equipment and measuring instruments that require care and conditions for their functioning.

STORAGE

The storage areas are designed and built to ensure Good Storage and Distribution Practices, comply with the conditions of cleanliness, temperature and relative humidity required by the type of supplies and/or products, and carry out monitoring and verification .

LABORATORY EQUIPMENT

Physical chemistry:

  • – Liquid chromatographs (UHPLC)
  • Dissolver
  • IR chromatograph
  • Measuring equipment for physical tests

LABORATORY EQUIPMENT

Microbiology:

  • Laminar flow hood
  • Medical Stoves
  • Medical Ovens
  • Incubators
  • Autoclaves

THE AREAS, MANUFACTURING EQUIPMENT AND PROCESSES REQUIRE CRITICAL SYSTEMS SUCH AS:

HVAC, SISTEMA DE AIRE ACONDICIONADO Y CALEFACCIÓN

HVAC, AIR CONDITIONING AND HEATING SYSTEM

COMPRESSED AIR

WATER FOR USE PHARMACIST

SYSTEM OF DUST EXTRACTION

SYSTEM OF POWDER COLLECTION

THE WAREHOUSES HAVE AREAS OF:

  • RECEPTION OF SUPPLIES
  • SAMPLE CHECK
  • -ASSORTMENT
  • -SHIPMENT
  • STORAGE OF RAW MATERIALS AND
    PACKAGING MATERIAL WITH AREAS
    OF :

    • QUARANTINE
    • APPROVED
    • RETURNS
    • FINISHED PRODUCT

THE PRINTED MATERIALS FOR THE CONDITIONING ARE STORED IN AN AREA WITH CONTROLLED AND RESTRICTED ACCESS, SAME THAT IS CONSIDERED AND DELIMITED WITHIN THE WAREHOUSE

HVAC, SISTEMA DE AIRE ACONDICIONADO Y CALEFACCIÓN

RECEPTION OF SUPPLIES

SAMPLE CHECK

HVAC, SISTEMA DE AIRE ACONDICIONADO Y CALEFACCIÓN

APPROVED AREA 1. RAW MATERIALS

APPROVED AREA 2. MATERIAL OF PACKAGING AND PACKAGING

PRODUCTION AREA

ETIQUETADORA TECNI PAC M4-189 CAPACIDAD: 40 A 80 PZS/MIN.

TECNI PAC M4-189 LABELLER CAPACITY: 40 TO 80 PCS / MIN.

BLISTEADORA UHLMANN UPS 300 CAPACIDAD: 50 A 35 GOLPES.

UHLMANN UPS 300 BLISTER MACHINE CAPACITY: 50 TO 35 STROKES.

MANESTY TABLET MACHINE BB4 WITH 35 STATIONS. CAPACITY: 2,100 TABS / MIN.

AREA DE ACONDIONADO SECUNDARIO

SECONDARY CONDITIONING AREA

HVAC, SISTEMA DE AIRE ACONDICIONADO Y CALEFACCIÓN

KAIXINLONG NJP ENCAPSULATOR CAPACITY: 480 CAPS / MIN.

MEZCLADOR DE PANTALÓN CAPACIDAD: 80 KG.

PANT MIXER CAPACITY: 80 KG.

Laboratory equipment

Cromatógrafos de líquidos (HPLC) Ultimate 3000.

Liquid Chromatographs (HPLC) Ultimate 3000.

DISOLUTOR HANSON SR8 PLUS

EQUIPMENT FOR PHYSICAL AND CHEMICAL TESTING

WORK AREA TO PERFORM TESTS AND/OR ANALYTICAL TECHNIQUES

CAMPANA DE FLUJO LAMINAR VECO

VECO LAMINAR FLOW HOOD

FELISA OVENS AND FISHER, BINDER AND FELISA INCUBATORS

AUTOCLAVES AESA Y FIGURSA

AUTOCLAVES AESA Y FIGURSA

CLIMATIC CHAMBERS: CARON 6030 AND LUNAIRE