The laboratory

Studio Ambiente S.r.l. has acquired over the years experience and technical expertise in the execution of microbiological and physical analysis on medical products and devices as well as cosmetics and biocides. The analytical offer is able to support companies also for the execution of chemical analysis and biocompatibility test, through the collaboration with qualified external laboratories, identifying the appropriate analysis to fulfill regulatory and mandatory requirements of the pharmacopoeia, standards, guidelines, directives and applicable laws.

All tests are carried out according to protocols regulated in European Standards of reference or official guidelines and recognized at European and international level (EU Pharmacopoeia, ISO standards, FDA guidelines …). The laboratory employs qualified technical personnel able to satisfy specific and dedicated requests such as the development of new methods or the development of experimental tests.

The company is in an area of about 500 square meters inside a commercial use building.

In the area dedicated to the offices are located the consulting activities, a sales office, a technical secretariat where the activities of acceptance of samples are carried out, a meeting room and management office. The laboratory area is divided into a warehouse area, a reagent preparation and storage area, an analytical area dedicated to non-sterile processes and an analytical area for sterile processes, an ISO 7 class clean room with an ISO 5 laminar flow cabinet. In the analytical area there are class A (ISO 5) microbiological 5 laminar flow cabinet, climatic rooms for ICH stability studies, incubators dedicated to microbiological analysis and thermostats for accelerated ageing for shelf-life studies, steam autoclaves for soil preparation, electronic dynamometer with motorised stand dedicated to packaging tests and further advanced technical equipment.

Product analysis

Studio Ambiente’s analytical offer includes the following tests:

ANALYSIS ON PRODUCTS CARRIED OUT INTERNALLY

  • Sterility test on product;
  • Sterility test on biological indicators;
  • Vitality tests on biological indicators;
  • LAL TEST – research of bacterial endotoxins;
  • Bioburden test with detection of pathogens, sporigens, enterobacteria;
  • Bacterial and fungal typing;
  • Release of foreign particles or particle count under the microscope;
  • Absorbance and transmittance;
  • Biocidal efficacy test (bactericide, fungicide, mycobactericide, sporicide) in suspension or on surface on chemical products for disinfection according to UNI standards and in GLP regime for the registration of biocides;
  • Challenge test;
  • Antimicrobial efficacy according to ASTM E2180;
  • Stand Alone Test and Discard date;
  • Microbial Ingress Test on connectors;
  • MIC test according to Kirby Bauer method;
  • Stability test in simulated use.

PROCESS VALIDATION

Studio Ambiente, through its laboratory staff, supports companies carrying out validations of special processes such as:

 

  • Validation of medical devices shelf life with accelerated and / or natural aging procedure;
  • Validation of medical devices stability according to ICH guidelines;
  • Validation of packaging process (operational qualification (OQ) and performance qualification (PQ));
  • Validation of steam sterilization process in situ;
  • Validation of dry heat sterilization process in situ;
  • Validation of depyrogenation process in situ;
  • Validation of aseptic filling process by media fill;
  • Microbiological performance qualification for ETO and ionizing radiation sterilization;
  • Validation of medical devices sterilizability;
  • Validation of medical devices cleaning;
  • Validation of medical devices reprocessing by simulating practical conditions of use;

ANALYSIS IN PRODUCTION ENVIRONMENTS ANALISI NEGLI AMBIENTI PRODUTTIVI

The analytical offer for customer analysis, through dedicated instrumentation, includes the following test, which can be performed in production environments such as clean rooms, laminar flow cabinets and clean rooms.

 

  • Particle analysis;
  • Microbiological analysis of air by sedimentation or by instrumentation (with SAS)
  • Microbiological analysis of surfaces;
  • Determination of particle class recovery time;
  • Determination of ambient luminosity;
  • Determination of temperature and humidity;
  • Determination of the number of air change per hour.

Downloadable forms

Below you will find our downloadable forms:

Analysis request form