Altiorlab is the first ISO 17025:2018 certified Accredia Centre that can offer calibrations in compliance with ISO 21501-4:2018 as required by ISO 14644-1. 

What makes us different

Unlike other laboratories, we are the first ones in Italy to issue the declaration of conformity to ISO 21501-4:2018. This is a service that we can perform on site at our customers’ workplace.

Our customers

We help companies to comply with standards 14644 -1:2015 / 21501- 4:2018 and other requirements inspectors check for. In particular, we help companies that need to carry out calibrations at an ISO 17025 certified centre.

QSGroup is Comecer’s sole and official service provider in Italy. Our company offers maintenance contracts for barrier technology: isolators, rabs and containment systems. 

Our services:

Installation of isolators 
IQ/OQ/PQ Qualifications
Maintenance throughout the life cycle of the isolator

SAT (Site Acceptance Test)

We support our clients throughout the entire life cycle of the equipment, offering both regular and extraordinary maintenance of the machine. 

Preventive maintenance  

We periodically inspect the equipment to prevent failures, thus preserving the integrity and improving the reliability of our products. 

Technical training  

We guarantee adequate training to use our products (both basic and refresher courses). We organize technical courses for the training of first-level maintenance operators (L1). 

Assistance for the automatic glove integrity tester

Performed with SpeedyGlove, a portable battery-powered device capable of performing leak testing of gloves installed on isolators or RABS. 
We are the only ones in Italy, trained by the parent company, to perform IQ/OQ/PQ for the Speedy Glove. In addition to this, we also offer an annual calibration service and take care of the preventive and extraordinary maintenance of the instrument.

QSGroup is the only official service provider in Italy to offer calibration and maintenance of Sievers TOC analyzers. 

Thanks to an extensive network of Sievers/GE Suez TOC analyser service technicians, we can guarantee that we are always close by and ready to assist clients. This way one can get the machine to operate again fairly quickly. 

We are the only ones in Italy to offer a service with technicians trained and certified by the parent company itself. 

The advantages for our clients:

Historical and direct relationship with the parent company Suez/Ge Water. 
Certified consumables and original spare parts under warranty.  
We apply the same high standards as the parent company. 
Different types of maintenance contract.

With over 20 years of experience in the sector, QSGroup offers validation and qualification services in the pharmaceutical sector.  

Thanks to continuous training, in-depth studies and long-standing relationships with some of the most important companies on the international market, we have a deep knowledge of cGMP, FDA, GAMP, ISO and ANNEX regulations.  

We can assist with the validation of tools and equipment used in pharmaceutical, biotechnological and chemical processes as well as. Furthermore, we have an in-depth knowledge of the advanced therapy and research sector.  

We have a division dedicated exclusively to specialized GAP Analysis, Risk Analysis and specific consulting services for monitoring systems within the areas classified according to ISO 14644. 

After founding our ISO 17025-4:2018 certified Altiorlab laboratory, we are also able to help companies with requests related to this standard. 

Our specialized services

With over 20 years of experience in monitoring systems, we can offer high value services for our customers’ monitoring systems, including:

Ideation and implementation IQ/OQ/PQ protocols in cleanrooms and on GMP variable monitoring systems (particle, microbiological, t°/RH/Δp, O2, specific parameters), HVAC systems, isolators, glove boxes, hoods, pass boxes, autoclaves as well as transfer systems.

  • Ideation and implementation IQ/OQ/PQ protocols in cleanrooms and on GMP variable monitoring systems (particle, microbiological, t°/RH/Δp, O2, specific parameters), HVAC systems, isolators, glove boxes, hoods, pass boxes, autoclaves as well as transfer systems.
  • TOC metrological chain control with NIST samples for SCADA.
  • Smoke study services.
  • Validation.
  • HEPA/ULPA absolute filter integrity test.
  • TOC qualification and requalification with specific protocols for data integrity.
  • Thermo Hygrometric mapping of warehouses, climatic cells and refrigerators.
  • Qualification and requalification of portable OPC meters with specific protocols for data integrity.
  • Evaluation of particle contamination classes (At rest and In operation).
  • Qualification and requalification of HVAC systems: check instrument calibrations, air speed control, differential pressure check, filter integrity check.
  • Verification of compliance with 21 CFR, part 11.
  • Preparation of Impact assessments, Gap analysis and Risk analysis.
  • Calibration of instruments on-site with our mobile laboratory.
  • Calibration and certification of potentiometric, KF, volumetric and coulometric holders.
  • Calibrations and certifications of pHmeters, laboratory conductivity meters, scales, thermostatic baths, melting point and stoves.
  • Calibration of reference instrumentation in our accredited laboratory (LAT Center n.266)

How we work

We believe that there are 7 points to achieve a perfect clean room:

1 As-built analysis of the particle monitoring system in the departments involved (FMS Sample Line Configuration)
2 As-built identification of representative sampling points with worst case identification, verification of particle probe geometry, study of particle decay in the pipeline. 
3 Qualification and upgrading study, verification that the system as a whole meets the efficiency requirements to be used according to the standards.
4 Document listing the laboratory results and improvement recommendations, Validation Summary.
5 Field application of what described in point 4.
6 ISO 21501-4:2018 calibration of meters on mobile laboratory ISO 17025:2018 at the customer’s workplace.
7 Flow Switch, QE and LSAPC Maintenance of FMS, data integrity compliance analysis (ISO 21 CFR – 11).

Thanks to our Altiorlab subsidiary (Accredia centre no. 266, ISO 17025:2018 certified), QSGroup can carry out calibrations on particle counters in compliance with ISO 21501-4:2018. 

This service is the first and only one, to date, on the Italian market. It allows companies to be certified and implement very high quality standards.  

Our expert technicians can travel to a customer’s workplace or instruments can be sent to our laboratories. 

3 options available:

Basis
The customer sends the instrument to our laboratories

Pick Up Me
One of our technicians travels the customer’s workplace, disassembles the instrument and takes away the part that needs to be repaired or checked. 

Just On Site
Our technicians reach the customer’s workplace and intervene directly on site.

Our company is one of the few in Italy and Europe to offer calibrations and validations at a client’s workplace (on-site) with a state-of-the-art mobile calibration laboratory.  

The Just On Site service is the perfect combination of 3 services:

  • Accredia certifications (ISO 17025:2018)
  • Calibrations at a client’s workplace with mobile laboratory
  • Downloadable certificates from online portal (certificates are therefore always available)

Features:

  • Vehicles are equipped with the latest technology.
  • Power inverters that allow us to work in any place, even without power supply. 
  • State-of-the-art compressed air and FM system.
  • HVAC system in compliance with ISO 17025:2018. 
  • Workstation with computer, printer, electrical sockets, WiFi.
  • Controlled thermo-hygrometric conditions thanks to isothermal insulation.
  • Refrigerators for standard storage with temperature control in case of power failure up to 48h.
  • Low ecological impact, photovoltaic panels with accumulation in slow release batteries.
  • Engine Euro 6.2. 
  • 9-speed automatic transmission. 
  • 210 hp, 470 nM torque. 

Advantages:

  • Avoid shipping and packaging costs.  
  • Reduce rental costs for back-up equipment.  
  • Reduce the costs of personnel dedicated to the preparation and sending of the equipment by avoiding the normal administrative process of creating and sending the necessary documentation. 
  • Integrate, where necessary, on-site validation services.  

Devices on which we operate:

  • Particle counters (handheld, portable and fixed monitoring systems).
  • Microbiological Impactors.
  • Data Loggers. 
  • Sensors of all GMP variables. 

Certifications:

  • Thanks to the Accredia/ILAC-MRA certification (ISO 17025:2018) of our subsidiary Altiorlab we are the only ones in Italy to provide declarations of conformity to ISO 21501-4:2018 as indicated by ISO 14644-1: 2015. 
  • We can also work with clients abroad. We currently have certifications in 12 different countries: Italy, Switzerland, Germany, France, Portugal, England, Malta, Albania, United Arab Emirates, Tunisia and Brazil. 
  • Our certifications include over 130 particle counters.