Services | Facilities & Equipment

About Us

• ReComS Laboratories provides services in analytical, microbiology and method development to the pharmaceutical, medical devices, cosmetic and food industries.
• Founded in 1992 under Accupharma Research and Scientific Consulting Inc. On 2005, it was acquired by ReComS Group.
• ReComS Laboratories is the largest single-site testing lab for the pharmaceutical, medical devices, food and healthcare industries in Puerto Rico.
• We are a Quality Control Laboratory.
• We are a Food & Drug Administration (FDA) registered facility.
• We are audited by major pharmaceutical clients in yearly basis.

ReComS Laboratories is built on the following
General Strategic Approaches:

• Quality Oriented
• Market-Driven
• We are focused on Customer Care
• We have a Committed Workforce

We are working to make ReComS Laboratories your preferred choice for Product & Environmental Testing!

Eric R. Olivieri Founder, Former President, Chairman, CEO (1956-2006)

Mission

To provide reliable Quality Laboratory and Scientific Consulting Services at a competitive cost to the pharmaceutical, healthcare, medical devices and food industries.

Vision

We will be the premier Laboratory Service Supplier for the Drugs, Healthcare, Medical Device and the Food Industry in Puerto Rico, USA and the Caribbean.

Highlights

• ReComS Laboratories is registered with the Food & Drug Administration (FDA).
• It is inspected by the FDA & found to be in compliance with applicable regulations and in good standing.
• ReComS Laboratories is routinely audited by major pharmaceutical & medical device companies.

Why Us?

Check out our competitive advantages:

• Local resource versus laboratories located outside Puerto Rico
• Our expertise in the pharmaceutical and medical devices industry
• State-of-the-art equipment
• Cost effectivenes

Our Services

Analytical Laboratory

• Laboratory Testing Support
  Provide results of the analyses performed to raw materials, finished product, packaging components following compendia and client’s procedures
  
  
• Raw Materials Testing Perform the analysis of raw materials as established in the USP/EP/JP/BP Pharmacopoeias or clients test methods.
  
  
• Finished Products / Release Testing
  Provide results of the analyses performed to a finished product, such as HPLC, GC, Atomic Absorption, Moisture, Identifications, Dissolution, among others
  
  
• Cleaning Sample Testing Perform the analysis of Cleaning Validations samples
  
  
• Water Sample Testing Perform the analysis of samples of Water Systems such as USP and EP
  
  
• Residual Solvents
  
  
• Assay and Impurities
  
  
• Organic Volatile Impurities
  
  
• Dissolution
  
  
• Compendial Testing

Microbiology Laboratory

• Laboratory Testing Support
  Provide a high variety of services related to laboratory testing in the microbiology field using compendia or customer methods.
  
  
• Raw Material, In Process and Finished Product Testing
  Testing of raw materials, finished products and in process samples following USP, EP and JP requirements. This includes the following tests:




▪	Microbial Limit Tests
▪	Microbial Enumeration Tests
▪	Microbiological Procedures for Absent of Specified Microorganisms
▪	Antimicrobial Effectiveness Testing



• Bacterial Endotoxins Test (LAL) Detection of bacterial endotoxins that may be present in or on the samples using LAL by gel-clot techniques.
  
  
• Microorganism Identification
  Our personnel are trained in the microorganism identification (Bacteria. Fungi, and Yeasts). The identification process is performed using Vitek, Biolog and API.
  
  
• Disinfectant Effectiveness Studies
  Determine the effectiveness of the disinfectant use to clean the working areas and laboratory equipments. These studies are performed with different types of microorganisms and surfaces.
  
  
• Environmental Sample and Testing
  Samples are collected at the client facilities by trained personnel. The samples are refrigerated and transported to the laboratory for further testing (if required), incubation and reading. Also, trends reports are prepared as per clients’ request.
  
  
• Compressed Air Sampling and Testing
  Samples are collected at the client facilities by trained personnel. The samples are refrigerated and transported to the laboratory for further testing (if required), incubation and reading.
  
  
• Biological Indicators Population Determination and Testing Determination of biological indicators population according to USP. Incubation services for biological indicators and results interpretation.
  
  
• USP/EP Water Testing
  
  
• Facility Validations
  
  
• Microbial Limits
  
  
• Yeast and Mold Identification
  
  
• Product Release Testing
  
  
• Bioburden Testing
  
  
• Antimicrobial Effectivenes

Method Development Area

• Analytical Methods Transfer
  The components of a successful method transfer include: Training, Familiarization Experiments, Method Transfer Protocol, Transfer Study Design, and Method Transfer Report.
  
  
• Analytical Methods Validation
  Typical performance characteristics that we considerer are: specificity (selectivity), linearity, range, precision (repeatability, intermediate precision, and reproducibility), accuracy, detection limit (LOD), quantitation limit (LOQ), system suitability, stability, and robustness.
  
  
• Cleaning Methods Validation
  Typical performance characteristics that we consider are: specificity (selectivity), linearity, precision (repeatability and intermediate precision), accuracy, swab recovery, rinse recovery, stability, and system suitability.
  
  
• Computer System Validation (CSV)
  The parameters that we evaluate are: System Documentation, Electronic Records and Signatures, Software Vendor Evaluation, Testing (application/platform/network), Training, Security, Business Continuity Plan, Change Control, Periodic Review, Documentation Storage, etc.
  
  
• Laboratory Instrumentation Qualification
  The extent of qualification required is a function of the complexity of the laboratory instrument. The parameters that should be considered, but not limited to, are: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  
  
• Laboratory Investigations Support
  Coordinate and/or conduct laboratory investigations to determine assignable causes of atypical or “Out-of-Specification” (OOS) results.
  
  
• Training and Seminars
  ReComS Laboratories, Inc. provides many trainings and seminars regarding new technology and analytical techniques. Analyst’s qualification and refreshment required maintaining the compliance status of your operations.
  • Empower™ Level 1 Training
  • Empower™ Level 2 Training
  • cGMPs
  • cGLPs
  • 21 CFR Part 11
  • Validation and Transfer of Analytical Methods
  • Guideline for Analytical Methods Transfer
  • Others
• Validations

Instrumantation

• HPLC
• Atomic Absortion
• Total Organic Carbon
• FTIR
• Gas Cromatography (Headspace GC and FID)
• UV Spectrophotometry
• Karl Fisher

Facilities and Equipment

Equipped with modern Hi-Tech Scientific equipment & instrumentation such as:

• HPLC & GC connected to the EMPOWER System
• Atomic Absorption
• FTIR
• TOC
• UV
• Dionex
• Autoclave
• Vytek / Biolog
• Polarimeter