Validation of Manufacturing Processes and Analysis Methods

Process analysis
Protocol preparation
Execution of the validation, tracing of manufacturing batches
Statistical analysis of the process variables
Preparation of validation reports
Implementation of identified improvements
Continuous verification of the validation status

Physical-chemical and Microbiological Quality Control

We count with a broad quality control and microbiology control laboratory for the performance of tests related to:

Sampling and analysis of raw materials and products
Analysis of packing and packaging materials
Sampling and analysis of environments

BPL-Certified analysis methods and analytical techniques:

Physical Analyses

Technique Description, Dimensions, functional testing for packing and packaging materials, gravimetry (Loss due to drying and weight, Residue on Ignition, filling weight, sulfated ashes, others), Solubility, Conductivity, pH, refraction index, polarimetry, Density / specific gravity, siege particle size, viscosity, hardness, friability, tightness, disintegration.

Physical-Chemical Analyses

Threshold testing
Chemical-reaction testing
Spectrophotometry-UV/VIS/IR
High-Performance Liquid Chromatography– HPLC
Gas Chromatography GC
Thin Layer Chromatography TLC
Potentiometry
Volumetry
Karl Fischer water content determination
Dissolution

Microbiological:

Mesophilic, fungi and yeast recount testing
Preservative-efficacy testing
Identification of specific microorganisms

Studies of:

Analytical method validation

We guarantee reliability with respect to the results issued, and we adhere to the specific requirements of each one of our clients, ensuring maximum quality in our processes.

Materias primas.
Material de envase y empaque.
Producto.

Storage and distribution

Purchase of Raw Materials and Packaging Materials:
Experienced in negotiating Raw Materials and Packaging Materials for the pharmaceutical industry
Product storage:
1. Experienced in handling products of the Pharmaceutical Industry and products of the Chemical Industry.
2. We handle various levels of hazardousness classified in accordance with the Globally Harmonized System (GHS) of the United Nations.
Management of Exports:
Management of EXW, FCA and FOB Export processes

Other Services Altea