PHARMACEUTICAL INDUSTRY

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Jeremy Harrington
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1 PHARMACEUTICAL INDUSTRY

THE COMPANY 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

Our range of products for stability, conservation and freezing tests, ranging from 48 litres benchtop chambers to visited chambers exceeding 200,000 liters volume.

3 THE COMPANY 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 litres benchtop chambers to visited chambers exceeding 200,000 liters volume. All our equipment is tested in our company before being sent to the customer, guaranteeing the maximum quality to our clients. QUALIFICATION The climatic tests for stability in pharmaceutical substances require very long periods of time for the approval of pharmaceutical products. In order to ensure the correct functioning of the Chambers during the test, the climatic chambers must pass a qualification. DQ, Design qualification IQ, Installation qualification OQ, Operational qualification PQ, Performance Qualification This qualification includes all documentation relating to the validation of the chamber plan. To ensure the maximum reliability of the systems, the qualification can be performed in the customer's own premises. MAINTENANCE Our maintenance service is available on an ongoing basis, ensuring technical assistance during the week, not exceeding 48 hours in Spain, after the notification of failure. Likewise, if the judgment does not require serious, we provide phone support for the realization of fast maintenance, carried out by its own service staff. Ask for our maintenance contracts. CALIBRATION DYCOMETAL has its own calibration laboratory, LCIS, to meet the requirements of the client according to standard UNE-EN-ISO/IEC 17025:1999. LCIS offers the completion of certificates of calibration temperature and humidity with metrological traceability. With all our equipment is included: electrical and mechanical diagrams, declarations of conformity, CE certification, and a list of components recommended for maintenance. 02_03

CHAMBERS COOLING & FREEZING TO STORE PHARMACEUTICAL PRODUCT

standards recommend conservation of the pharmaceutical

ASPECTS If the offer and diversity in our ovens is extremely

and WALK- IN equipment or compact systems with lower load

4 CHAMBERS COOLING & FREEZING TO STORE PHARMACEUTICAL PRODUCT ACCORDING ICH GUIDELINES CV SERIES The pharmaceutical standards recommend conservation of the pharmaceutical products under the following thermal conditions GENERAL ASPECTS If the offer and diversity in our ovens is extremely wide. It is not least in our cold storage buildings 4ºC ±3ºC -20ºC ±ºC Modular Walk-in Chamber, CV. 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. Static Freezer Chambers, CVE.

COOLING & FREEZING MAIN FEATURES Interior and Exterior, manufactured in stainless steel. CFC free high density (40kg/m3) polyurethane insulation with low GWP & zero ODP effect.

Self closing doors with stay open feature. Plastic coated wire shelves (530x410), adjustable height and easy removal. Stainless steel adjustable legs up to 200 mm.

5 COOLING & FREEZING MAIN FEATURES Interior and Exterior, manufactured in stainless steel. CFC free high density (40kg/m3) polyurethane insulation with low GWP & zero ODP effect. Sealed interior floors and rounded cabinet corners. Heated door frame to avoid accumulation of ice. (Only freezing models) Easy removal triple chamber gasket. CV-500 Integrated door handles. Self closing doors with stay open feature. Plastic coated wire shelves (530x410), adjustable height and easy removal. Stainless steel adjustable legs up to 200 mm. (Optional: casters) Evaporator coil coated with anti-corrosion material Evaporative tray. Control of the final defrost temperature. CV-1000 Hot gas defrost. (Only freezing models) STANDARDISED MODELS MODELS: CV-0/500 CV-0/1000 CV-25/500 CV-25/1000 Volume: Liters External Dimensions: Height Width Depth Workspace: Height Width Depth Temperature Range: ºC +2ºC/ +8ºC From room to -25 Shelves: Cooling System: Forced Air Forced Air Gas: R-134A R-404A Power Supply: 220 V 60 Hz 220 V 60 Hz Power: watt * For other configurations of different volumes, please contact DYCOMETAL. 04_05

6 CLIMATIC CHAMBERS PREPARED FOR STORAGE OF PHARMACEUTICAL SAMPLES ACCORDING WITH GUIDELINES-ICH/FDA 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: 25ºC/60% RH (minimum 12 months) Long middle-term Study: 30ºC/65% RH (minimum 6 months) Accelerated Study: 40ºC/75% RH (minimum 6 months) For substances or pharmaceuticals in semi-permeable packaging, the test conditions have been set out under the following guidelines: Long-Term Study: 25ºC/40% RH (minimum 12 months) Long-Term Study: 40ºC/25% RH (minimum 12 months) During these tests you should ensure a deviation of temperature ±2ºC and in relative humidity of ±5% HR. Guidelines shall be valid for the European Union, Japan and United States, but depending at all the country of destination stability testing may be different or not be necessary at all.

COMPACT CLIMATIC CHAMBERS CLIMATIC CHAMBERS COMPACT Extremely robust, compact construction, or monoblock, chambers are built on a structure of steel tube and, externally, a base sheet of zinc coated

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

Humidification system with range from 10% to 98% RH.

7 COMPACT CLIMATIC CHAMBERS CLIMATIC CHAMBERS COMPACT 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 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 regulations concerning the installation of thermal-acoustic chambers. Available in 4 standard temperature ranges: 0ºC, -25ºC, -40º and 70ºC to +180ºC. Humidification system with range from 10% to 98% RH. All models are manufactured according with the parameters established in the Guideliness ICHFDA Wide range of abilities useful Interior: from 48 litres to 2500 litres. Height adjustable shelves Observation window. CM-0/48, Benchtop model Chambers with 1/2/3/4 horizontal compartments. Chambers with 2 vertical compartments. Constructions in a single chassis with independent control and operation systems. Ideal for limited spaces. CCK-40/1000, temperature and humidity compact chamber CCK2V-0/300, Chamber with two separate compartments. 06_07

CLIMATIC CHAMBERS CM ICH SERIES Designed within the requirements of the guidelines ICH Q1A and Q1B,

without compromising in the volume of the enclosure of tests.

CM series offers an economical solution and low operating costs.

8 CLIMATIC CHAMBERS CM ICH SERIES 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. These models have two volumes depending on the number of samples to be tested by the customer. CM series offers an economical solution and low operating costs. Optional Elements: IQ, OQ and PQ documentation. Additional shelves. Tempered glass doors. Additional data logging system Castors. Lighting system for photostability tests. Touch Screen panel. Reservoir of water, 80 litres. ACTA, control panel system Lighting system for photostability tests

COMPACT CLIMATIC CHAMBER MAIN FEATURES Exterior and interior made entirely from AISI 304 stainless steel.

Defrost drain in interior. 1 Access port of 80 mm ø with cap. Interior shelves and supports easy to remove for cleaning.

Height-adjustable stainless steel legs. (Optional casters) Shelves included (4 in CM-0/600 and 8 in CM-0/1200).

CM-0/600 CM-0/1200 STANDARDISED MODELS Model CM-0/600 ICH CM-0/1200 ICH Volume liters 534 1158 Height mm 1370 1370 Workspace: Width mm 600 1300 Depth mm

9 COMPACT CLIMATIC CHAMBER MAIN 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. Defrost drain in interior. 1 Access port of 80 mm ø with cap. Interior shelves and supports easy to remove for cleaning. Designer doors with built-in handle and pivot hinge with block hinges. LED light, in glass door models. Easy-to-change triple chamber door seal. Height-adjustable stainless steel legs. (Optional casters) Shelves included (4 in CM-0/600 and 8 in CM-0/1200). Temperature and humidity capacitive sensor. Internal safety devices for protection of product (Optional). CM-0/600 CM-0/1200 STANDARDISED MODELS Model CM-0/600 ICH CM-0/1200 ICH Volume liters Height mm Workspace: Width mm Depth mm Height mm External Dimensions: Width mm Depth mm Temperature Range: ºC +10 to +50 Temperature Stability:* ºC ±0,1 ºC to ±0,3ºC Temperature Uniformity:* % C ±0,5 ºC to ±1,5ºC Humidity Range: % RH 50 to 90% RH Humidity Stability:* % RH ±1%RH to ±3%RH Shelves: 4 8 Weight: Kg Power: V 220V 50Hz. 08_09

MODULAR CONSTRUCTION CHAMBERS WALK-IN TAILOR-MADE CHAMBERS The solution for the storage of large batches of pharmaceutical products in controlled climatic

The chambers are standardized or "turnkey" systems to suit the Customer preference, adapting the interior volume or the external dimensions to the existing

10 MODULAR CONSTRUCTION CHAMBERS WALK-IN TAILOR-MADE CHAMBERS 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 litres to more than 300,000 litres. With great stability, environmental conditions are set to ranges of temperature between 20 C and 70 C, with humidity between 20 and 95 HR. Temperature and Humidty Climatic Chambers with independent control.

MODULAR CLIMATIC CHAMBER 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

Condensing units units housed in separate module or prepared to weather. Interior furniture: shelves with stainless steel frames and trays in stainless steel or polypropylene.

11 MODULAR CLIMATIC CHAMBER 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 units housed in separate module or prepared to weather. Interior furniture: shelves with stainless steel frames and trays in stainless steel or polypropylene. Monitoring of the variables of temperature and humidity by Registrar, paper registration systems, etc Validation of the entire system: Validation plan, DQ, IQ, OQ and PQ. Establishment of maintenance contracts. Interior Furniture STANDARDISED MODELS CM-0/ MODELS: CM-0/4000 CM-0/9000 CM-0/16000 CM-0/20000 CM-0/26000 Volume: Liters External Dimensions: Height mm Width mm Depth mm Workspace: Height mm Width mm Depth mm Temperature Range: ºC +10 tp +50 Temperature Stability: ºC ±0,1 to ±0,3 Temperature Uniformity: ºC ±0,5 to ±1 Humidity Range: %HR 50% to 90% Humidity Stability: %HR ±1% to ±3% * Chamber settings can be developed on request of the customer: volume, temperature, humidity, etc.. ** The indicated data are concerning trials at a temperature of 23 C 10_11

The control system can optionally offers different interfaces to communicate online with the customer's own record, if you have it, as: RS- 232, RJ-485, Ethernet, etc.

12 SYSTEMS OF CONTROL & REGISTER Our control systems are simple and quick to operate, saving time for the user. 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, RJ-485, Ethernet, etc.. All chambers have optionally a system of registration for 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 requirements of the FDA 21 CFR Part 11. Secure traceability Electronic signature The operator signed comments Controls electronic signature The data will be available from any PC connected to the corporate network environment. Access is always safe, with login and password for each user.

source shall ensure the intensity of display lighting on the samples, according to the specifications of the regulations.

13 CHAMBERS FOR EXPOSURE TO THE SUN LIGHT FOR PHOTSTABILITY TESTS OF NEW ACTIVE SUBSTANCES AND MEDICINAL PRODUCTS. OPTION II, CPMP/ICH/279/95 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 regulations. 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. Its simplicity, functionality and low price, make this team, the ideal element for photostabilitystudies. 12_13

SOME REFERENCES: ALCALIBER, ALCONCUSI, ALMIRALL PRODESFARMA, ANTONIO PUIG, ASTUR PHARMA, BERLIMED GRUPO JUSTESA, BERNIA BIOTECH ESPAÑA, BOEHRINGER INGELHEIM, CENAVISA LABORATORIOS GRUPO SERRA PAMIES,

14 SOME REFERENCES: ALCALIBER, ALCONCUSI, ALMIRALL PRODESFARMA, ANTONIO PUIG, ASTUR PHARMA, BERLIMED GRUPO JUSTESA, BERNIA BIOTECH ESPAÑA, BOEHRINGER INGELHEIM, CENAVISA LABORATORIOS GRUPO SERRA PAMIES, COMBINO PHARM, GRUPO URIACH PLANTA, FARMACEUTICA, DERMOFARM, FARMA LIDER, FARMASIERRA, GRUPO REIG JOFRE PLANTA DE TOLEDO, GRUPO VITA PLANTA FARMACEUTICA, HELIOSAR SPAGYRICA, HOMEOLAB, ICN IBERICA, IFC-INDUSTRIAL FARMACEUTICA CANTABRIA, IPSEN PHARMA, KINESIA, LABORATORIOS ARGENOL, LABORATORIOS BELMAC, LABORATORIOS CINFA, LABORATORIOS GELOS, LABORATORIOS HIPRA, LABORATORIOS LAMONS, LABORATORIOS MEVET, LABORATORIOS SALVAT, LABORATORIOS VILARDELL, LABORATORIOS VIÑAS, LABORATORIOS VITAFARMA, LABORATORIOS ZOTAL, LACER, LILLY, MEDINSA, MOHES, VOVARTIS FARMACEUTICA, NOVARTIS CONSUMER HEALTH, OTSUKA PHARMACEUTICAL, PHARMA MAR, PIERRE FABRE DIV. FARMACEUTICA, ROCHE PHARMA, SANDOZ, SANOFI AVENTIS, SYNTHON HISPANIA, TECNILATEX, UNIVERSIDAD DE BARCELONA FACULTAD DE FARMACIA DYCOMETAL, EQUIPOS DE C.C.,S.L. Parc D`aCtivitats de Viladecans C/De la Ciència, VILADECANS (Barcelona) - SPAIN Tel. (34) Fax. (34) comercial@dycometal.com

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