STABILITY CHAMBERS -PHARMACEUTICAL MARKET
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GEnERflL BROCHURE PHflRmflCEUTICRL inDUSTRY .THE COmPRnY DYCOMETAL is a company with more than 25 years of experience in the development, design and manufacture of climatic chambers for the pharmaceutical sector, according to ICH and FDA standards. Our extensive experience in the industry has allowed new developments in product, with the most advanced technology. Our range of products for stability, conservation and freezing tests, ranging from 48 liters benchtop chambers to visited chambers exceeding 200,000 liters volume. All our equipment is tested in our company before being sent to the...

Cooling and Freezing Chambers CV, AC Compact Climatic Chambers CfTl Climatic Chambers CfTl ICH modular Climatic Chambers CITIm Control and Logging Exposure chamber of Sunlight Fotopanel

PHflRmflCEUTICRL COOLinG RnD FREEZinG CHRmBERS CHflfllBERS FOR COOLinG RnD FREEZinG TO STORE PHARmnCEUTICRL PRODUCT CV, RC SERIES General Features If the supply and diversity in our ovens is extremely wide, it is no less so in our refrigeration constructions. The pharmaceutical standards recommend conservation of the pharmaceutical products under the following thermal conditions: For this reason, we have in our manufacturing plan, modular and WALK-IN equipment or compact systems with lower load capacity. We have equipment with forced air circulation and cooling by static evaporation....

CLimflTICCHflmBERS FOR STABILITY TESTS OF PHARfllACEUTICAL SAITIPLES ACCORDinG LUITH "GUIDELinES-ICH/FDA" Geoeral Features Custom designed or with standard designs, we have a diverse selection of solutions according to your needs. Stability testing is an important element in the development of new medicines and pharmaceutical substances, being an essential point for the authorities granting licenses for the product. In general cases, products and pharmaceutical substances should be tested under the following conditions: • Long-Term Study: 25°C/60% RH (minimum 12 months) • Long middle-term...

PHRRmRCEllTICfll COmPRCT CLimRTIC CHRmBERS ’ Extremely robust, compact construction, or monoblock, chambers are built on a structure of steel tube and, externally, a base sheet of zinc coated steel, with oven cured acrylic paint (RAL 9010). Interior in AISI 304 stainless steel sheet (188), completely water tight and seamless Interior. Door painted according to RAL-9010. ■ Thermal insulation consisting of semi-rigid polyurethane foam of high density and very low coefficient of thermal conductivity, free of fluorocarbons, asbestos, lead oxide or mercury as stipulated in the environmental...

CLimflTIC CHflmBERS FOR STABILITY TESTS Cm ICH SERIES General Features Standardized designs of 600 and 1200 liters, with interior and exterior stainless finishes. Economic and large volume solution for stability tests. Simple to operate and install. Designed within the requirements of the guidelines ICH Q1A and Q1B, complying with the terms of both guidelines, vertical cabinets, facilitates the storage of large batches of samples. Its vertical design, allows you to easily integrate the chamber within laboratories with small space without compromising in the volume of the enclosure of tests....

PHRRmRCEUTICflL CLimRTIC CHRmBERS CfTl ICH fTlain Features Exterior and interior made entirely from AISI 304 stainless steel. Polyurethane insulation injected at high pressure, CFC free with a density of 42 kg/m3. Interior chambers with rounded corners for easier cleaning. Interior drainage. 1 Access port of 80 mm o with cap. Interior shelves and supports easy to remove for cleaning. Designer doors with built-in handle and pivot hinge with block hinges. Easy-to-change triple chamber door seal. Casters to move the chamber easily. Shelves included (4 in CM-0/600 and 8 in CM-0/1200). Pt-100...

COnSTRUCTIOn CHRfTlBERS TRILOR-fTlRDE CHRfllBERS CfTlm SERIES General Features The solution for the storage of large batches of pharmaceutical products in controlled climatic conditions. The chambers are standardized or "turnkey" systems to suit the Customer preference, adapting the interior volume or the external dimensions to the existing space. This means that the capacity of the chambers can go from 700 liters to more than 300,000 liters. With great stability, environmental conditions are set to ranges of temperature between +10° C and +50° C, with humidity between 50 and 90% RH. The...

PHflRmflCEUTICRL fTlODUlRR CLimRTIC CHRmBER fTlain Features Climate representation of any of the “Guidelines ICH/FDA" Interior panels manufactured in different materials: Lacquered sheet steel, stainless steel AISI 304 or AISI 316L. Reinforced stainless steel "non slip" flooring. Easily expandable chambers. One, or several compartments separated by dividers. Controlled air circulation with either turbulent or laminar flow. Condensing units housed in separate module or prepared to weather. Interior shelves with stainless steel frames and trays in stainless steel or polypropylene. Monitoring...

General Features The chambers are equipped with various alternatives of control, the basic system being the simple control of temperature and humidity. The control system can optionally offers different interfaces to communicate online with the customer's own record, if you have it, as: RS-232, All chambers have optionally a system for logging, monitoring and registration of the variables of temperature and humidity, one or several chambers at the same time. The system complies with the ICH Guidelines and with the re quirements of the FDA 21 CFR Part 11. • Secure traceability •...

PHflRmflCEUTICRL EXPOSURE CHRfTIBER OF SUnLIGHT CflBinET FOR EXPOSURE to SOLRR LIGHT FOR PHOTOSTRBILITY TESTS FOTOPRnEL We have developed a single cabinet or chamber aimed for photostability tests with lighting source in cool white fluorescent and near UV, this light source shall ensure the intensity of display lighting on the samples, according to the specifications of the standard, OPTION II Q1B. The main elements of the chamber are: • Current temperature display. • Timer to turn the lights on and off. • Hot air extraction. • Shelves and side fastening rails at different heights