Analytical Development
Unither with a global range of high-tech equipment and fully qualified operators is able to deal with requirements from development to stability studies and quality controls. Our organization is fully inspected by the Health authority (AFSSAPS).
Unither main areas of analytical expertise are as follows:
- Pharmaceutical development
- Development and validation of analytical methods
- Inter-laboratory transfer methods
- Stability studies to define product Shelf Life
- Quality control of pilot and clinical batches
- Write-up of registration files
Unither’ services are performed in strict compliance with GMP procedures.
Our analytical service is dedicated to deal with all customers requirements, even the most specific. Unither has ten fully qualified operators at your service, under the supervision of three pharmaceuticals engineers. Each finished record is approved by quality insurance and the Qualified Person.
With the following equipment, Unither can handle a large range of operations.
HPLC :
- AGILENT series 1100 including DAD and 2 gradients
- ALLIANCE WATERS 2690 (2 connected to dissolution batches)
- UPLC Waters
GC:
- AGILENT 6890 series GC System + HEAD SPACE 7694 sampler
DISSOLUTION:
- SOTAX Dissolution testing with automatic sampling and on line HPLC or UV connection
- Apparatus 1 (basker apparatus), 2 (paddle apparatus), and 3 (flow-trough cell), according to EP
Inhaler Testing:
- New NGI for metered Dose Inhaler testin
Our Analytical development services include:
- Molecule characterization
- Method development and validation
- Cleaning residuals development and validation
- Dissolution and drug release profiling
- Forced degradation studies
- Specifications development
Stability monitoring to ICH guidelines
Stability studies
- Expertise through a wide range of products, different validation of analytical methods as well as pre-formulation and shelf life improvement studies.
- Retrospective studies.
- On-going studies (bracketing and matrixing included).
- In-use studies.
- First opening studies, reconstitution studies.
- Follow-up studies.
Analytical Laboratory (Equipment, Staff and Documentation)
- Compliance with GMP, good Laboratory practice (GLP) and International Organization for standardization (ISO) certifications.
- Qualified instruments.
- Validated computerised systems.
- Well trained and experienced staff.
- Document control.
- System of documentation that assures current version of standard operating procedure (SOP).
- Out of specification (OOS), out of trend (OOT) and out of expectation (OOE) procedure.
- Analytical method transfer procedure.
- Process, data, report and protocols audited by and independent quality assurance unit.
- Analytical instrumentation (gas chromatography GC), high-performance liquid chromatography (HPLC), liquid chromatography-mass spectrometry (LCMS), head space and liquid oxygen analyser, atomic spectrometry, flame photometer, sub-visible particulate counter, Fourier transform Infrared (FTIR). Etc.)
- Microbiological testing (polymerase chain reaction (PCR), sterility and bacterial endotoxins assay for parenteral solutions, biological assessment of antibiotics, microbiological quality testing of pharmaceutical preparations).
Storage Sample Area
- Sample integrity.
- Organisation.
- Effective and reliable stability-sample tracking.
- Adequate segregation of samples → well organised and clean space.
- Security → limited access to samples.
- Documentation of samples custody.
- Correct labelling of identity.
- Well labelled bins or well marked shelves with dividers.
Stability Chambers
- Covering all ICH climatic zones.
- Ability to accommodate new conditions for clients who still require them.
- Routine calibration and validation.
- Continuous monitoring of storage conditions (temperature (T) and relative humidity (RH)).
- Consistent, reliable chamber monitoring and maintenance.
- Contingency plan for chambers breakdowns and comprehensive reporting.
Analytical Methods
- Development and validation protocols according to ICH and FDA requirements
- Audit trial.
- Old methods improving.
- Fast chromatography.
- LCMS methods development (adaptation of traditional HPLC methods to LCMS methods).
