Achieving product safety guidelines for the pharmaceutical industry

Pharmaceutical Industry

Pharmaceutical Industry Guide

business background

The drug is very sensitive to temperature. Producing sub-standard drugs can destroy a company. Use dry ice or gel packs to isolate and transport medicines to protect their quality and efficacy before they reach their destination.

Using an expanded polystyrene foam container, shallow channels on the tank promote air circulation, balance internal and external temperatures; or raise floor liners; interlock packaging to retain hot and cold airflow; or introduce other expensive packaging measures to maintain Drug temperature. However, under the conditions of poor temperature, the above measures may be invalid.

Drug shipments must be monitored and temperature changes during transportation must also be documented. Without such data, it is acceptable to document the temperature of the equipment used to transport and deliver the drug, and the clinical efficacy of the drug can therefore be interpreted as deceptive.

Medical products based on botanicals are particularly sensitive to temperature. Temperature recording is key from harvesting, storage, to processing.

Using a circular chart thermometer, the environmental chamber used for stability testing is compliant. Many companies have turned to computer-based environmental monitoring and alarm systems, but still need data loggers. Stability management requires verification of storage conditions, calibration of monitoring devices, permanent billing systems and traceability of samples after storage, testing and final deployment.

Although temperature-controlled transportation service facilities exist, third-party recording devices must also be used to record the actual temperature fluctuations that occur.

Some medicines, such as vaccines and antibiotics, require storage and handling at specific temperatures, otherwise they exceed the limit and lose their effectiveness. To ensure that these drugs are handled properly, time-temperature display labels are affixed to containers, pallets, and even to each package. Obviously, the color of the label changes when the drug is placed above the limit temperature.

Temperature labels use three techniques: dye diffusion, polymerization or enzymatic reactions.

Potential sales target

Ÿ Air transportation, such as: DHL Airlines.

包装 Packaging company.

Industry magazine

Ÿ Pharmaceutical Technology

Ÿ Drug Formula and Quality

Ÿ Drugs and Medicine Packaging

DeltaTRAK product use :

11062 Auto-Cal Jumbo Display Waterproof Probe Lab Digital Thermometer Automatic Calibration Large Screen Display Laboratory Digital Electronic Thermometer

唯一 The only difference from the 11060/11063 automatic calibration series ( NSF certification) is that the probe is round and does not penetrate and is marketed as a “ laboratory” thermometer. We do not require accuracy to reach the usual standard for laboratory thermometers, ±.5°F, but the user can calibrate to a specific temperature to achieve an acceptable range of accuracy. It is the ideal test tool for research, laboratories, veterinarians and blood banks.

Ÿ Waterproof.

Ÿ Very solid.

Ÿ °C/°F is easy to replace and is used worldwide.

Ÿ The reaction rate is 3 times faster than the common models on the market.

挂 The hanging hole on the back of the thermometer can be connected to a lanyard or chain to prevent loss.

Ÿ The Hold button locks the readings and makes it easy to test areas that are difficult to read.

Ÿ The large screen shows that the temperature reading is clear.

Ÿ The user can automatically calibrate to 0 degrees using ice water, and the test is accurate.

12207 Min/Max Alarm Digital Probe Thermometer Maximum / Minimum Alarm Digital Thermometer

型号 Model 12207, once configured, is suitable for long-term fixed testing at a certain point. For example, use it to monitor the temperature performance of refrigerators, cold storage, display stands, water tanks, etc.; or to test the ambient temperature of liquids, foods and other sensitive products.

内置 The built-in sensor displays the indoor temperature and an external probe sensor connected to a 10 ft / 3 m long wire to quickly adjust the test point temperature.

Ÿ You can set the upper and lower limits of the alarm temperature to realize the alarm function. It is a very affordable and easy to use QA inspection tool.

12213 Certified Refrigerator/Freezer Alarm Thermometer certified refrigerator/cold storage alarm vaccine digital thermometer

型号 Model 12213, will not be affected by the frequent opening and closing of the refrigerator door, the temperature is affected by the sharp change of the upper and lower, the temperature test is accurate.

内置 The built-in temperature sensor senses the room temperature; the external sensor is connected to a 3-meter long wire and sealed in a vial containing propylene glycol solution. The temperature of the propylene glycol liquid is roughly similar to the temperature of liquid medicines, injectables, vaccines, etc., which are usually stored in a liquid in a refrigerator or in a laboratory cold storage.

Ÿ Operating temperature range of 14°F-22°F (-10°C-50°C) The external probe sensor has a test range of -58°F-158°F (-50°C-70°C).

Ÿ It is mainly used in hospitals, emergency rooms, operating room pharmacies, laboratories, and monitoring the storage environment conditions of medicines, medicines and blood bags in refrigerators.

13307/13308 Thermo- Hygrometers are a valuable preventive maintenance and quality assurance tool.

监测 Monitor the temperature and relative humidity of hospitals, pharmacies, blood banks, clean rooms, walk-in coolers.

Ÿ Model 13307 Thermo -hygrometer with large LCD screen, °F/°C switching, minimum/highest temperature reading memory, freeze alarm setting option function, external thermistor probe with extension cord.

ŸModel 13308 with pin portable thermometer and hygrometer, the shell is bright and visible, not easy to lose

14010Electronic Circular Chart Temperature Recorder model 14010 electronic circular chart recorder

It is a reliable time and temperature recorder.

Ÿ 4 kinds of paper feeding speed: 6 hours, 24 hours, 7 days and 31 days. The three temperature ranges are: -40 ° C ~ -1 ° C, -30 ° C ~ 10 ° C and 10 ° C ~ 49 ° C, respectively for use in frozen, refrigerated and ambient air environments.

Ÿ An external stainless steel probe is used to measure the temperature of air, gas, liquid and semi-solids.

Ÿ °F or °C dual temperature mode. With 8 AA alkaline batteries, it provides continuous recording within 48 hours after a temporary power outage.

Ÿ The LED screen shows the current temperature. The chart provides a record. Charts and styluses are easy to replace.

14014Temperature Humidity Dew Point Circular Chart Recorder 14014 (220V) the temperature / humidity / dewpoint chart recorder

应用于 Used in cold storage facilities, greenhouses, processing rooms and laboratories to provide simultaneous monitoring of temperature and relative humidity.

四个 Four different chart speeds: 12 hours, 24 hours, 7 days and 31 days.

图表 The chart has either oF or oC. The recording range is -30 ° C ~ 50 ° C, relative humidity 10% ~ 90%. The dew point can also be calculated.

Ÿ The red pen tracks the temperature track, the blue pen tracks the humidity track, and the measurement data is permanently recorded on a circular drawing with a diameter of 165 mm.

Ÿ Easy-to-read LCD display and full-featured temperature over-range alarm features.

Ÿ The 48-hour backup battery provides power and ensures continued operation during temporary power outages.

18028/18030 Digital Display Environment Temperature Recorder LCD Ambient Temperature Digital Recorder

Ÿ 31 days / 62 days model with LCD display. Simultaneous detection and recording. It allows you to quickly and easily read the current ambient temperature, and can also provide permanent temperature record drawings for a permanent period of time.

Ÿ The LCD display size is 1.5” x 0.5” (3.8cm x 1.3cm); the window for viewing the chart is 2” x 2.8” (5cm x 7.1cm).

精致 Exquisite and lightweight, battery operated. It can be hung on the wall and can be hung up with a wire.

Ÿ Passed CE certification and environmentally friendly RoHS standards.

Ÿ It is mainly used for monitoring and recording in the facilities of health centers, hospital emergency rooms, operating rooms, laboratories, and pharmacies for a period of time and showing the current ambient temperature.

Ÿ In European countries, EU directives: All drug manufacturers must have temperature display and recording devices.

符合 Comply with the FDA's confirmation of the temperature distribution of the raw material manufacturing facility equipment, and establish the written procedures for equipment verification, maintenance, monitoring and control.

In-Transit Temperature Recorder 16000 Series transport temperature recorder

Ÿ Used to prove the temperature during transportation. Transport temperature recorder, become an indispensable part of the goods, it is used to provide temperature control properly documented.

Ÿ The meaning is:

The consignee can confirm that the goods are delivered in a safe temperature environment, thus affirming the product's safety and quality standards.

The shipper may choose the most suitable conditions for transporting the goods, but cannot control the temperature changes over the course of several days. transport       The temperature recorder can detect problems as soon as the cargo is loaded.

When it comes to insurance or legal compensation for quality problems, the transport temperature recorder is the only way to track the temperature environment during transport.

Ÿ Different carrier and receiver preferences, you will choose to use Analog Temperature Recorder or FlashLink Data Logger . The former, the mechanical paper temperature recorder, is simple and easy to use without connecting to a computer. But the latter FlashLink lightning-connected data meter provides more accurate, detailed, and real-world information, and can be analyzed graphically or sent to the world in an email form. Software that supports reading these files is available for free download from the DeltaTRAK web page.

Ÿ From a business perspective, transport temperature recorders are a recurring source of business. Every time a shipment is made, there will always be one or more such disposable transport temperature recorders being utilized.

Re-usable FlashLink Data Logger reusable Flash Link data logger

型号 Model 20200 can be programmed for a wide range of uses. It is a valuable tool for verifying the environmental conditions of stability testing, production processes, and long-term storage or transportation. It is not suitable for monitoring the environmental temperature of operating rooms, laboratories, pharmacies, etc., as well as the storage status of hospital refrigeration equipment products.

Ÿ Professional LCD real-time monitoring data meter, models 20261, 20268, 20269 are widely used.

Ÿ Effectively used to record the temperature of the refrigeration equipment in the facility to meet HACCP requirements. At some point, it is necessary to manually record the temperature data of the refrigeration equipment every 30 minutes. A reusable data logger simplifies this process, and you only need to download the data once a week. These highly accurate electronic data can be used for analysis, tabulation, archiving, and instant emailing. In just a few weeks, just saving time and manpower costs is enough to pay for the purchase of the data meter. A flashing warning light indicates that the alarm limit has been exceeded.

FlashLink Bio Logger uses biochemical data loggers in one go

型号 Model FlashLink Bio Recorder, model 20800-20803 , designed for vaccine transport in the life sciences industry, with a factory alarm temperature setting from 2°C to 8°C.

Ÿ Customizable alarm delay and skip alarm

Ÿ 30 minutes of preset delay

专利 Patent “Shadow RecordTM” guarantees that data is safe, even if the user forgets to start the recorder.

可选择 You can choose to print data using CT image printer or download to PC

Ÿ Selection of FlashPDF software (in compliance with FDA 21 CFR Chapter 11)

Infrared Thermometer 15036 Waterproof Infrared Thermometer

Ÿ IR- infrared thermometer provides QA/QC quality inspection department to quickly test the surface temperature of non-contact objects.

20615/20616 High Temperature Data Logger Wan waterproof high temperature stainless steel data logger

防水 Waterproof automatic device that records the temperature of the product during production and testing. When it is not appropriate to use the FlashLink data meter to test the temperature of objects such as liquids, containers, and objects, the pyrometer is most effective.

Ÿ Data can be downloaded to a computer for analysis.

型号 Model 20616 comes with a 24-inch flexible silicone wire on a 4-inch penetrating probe sensor.

FlashLink Wireless System wireless temperature and humidity real-time alarm monitoring system

Ÿ Can be used to monitor and record temperature and humidity in hospitals, operating rooms, emergency rooms, and laboratory facilities. From the central control room, up to more than 100 areas can be monitored simultaneously. The system is fully automated and reliable; data is collected every 60 seconds, and all data collected is tracked and recorded.

Ÿ Wireless temperature and humidity system is suitable for large-area multi-channel real-time temperature and humidity network monitoring, recording and alarm. Provide configuration according to user needs, continuously monitor and complete temperature and humidity management reports.

Ÿ More than 100 sensors can be arbitrarily placed in the required inspection areas, such as storage rooms, storage cabinets, refrigerators, cold storage, computer rooms, drying ovens, etc. It can also be used to test pharmaceutical production workshops, clean rooms, and cold storage facilities; as well as greenhouses, smoking rooms, and food production sites.

温度 The temperature/humidity data detected by the sensor is continuously collected and transmitted to the computer within 24 hours without any interference.

Ÿ The system's alarm function ensures that the contacts on the pre-set list of phone numbers are automatically dialed and reminded. The contact will receive the pre-recorded information and press the * button to confirm the notification.

Ÿ This system complies with FDA Part 21 CFR Part 11 to ensure a secure database management system. Recorded data is reviewed, verified, or printed as needed. Meet and exceed the regulations of HACCP, QA and laws and regulations regarding the maintenance of environmental monitoring records.

ISFETpH Meter 　 Acid and alkali

此类 This type of non-glass pH meter is easier to clean and use than glass.

型号 Model 24003 , better than ordinary pen glass acidifier . Easy to calibrate, easy to dry, and sized for placement in shirt pockets, it can detect pH from pharmaceuticals to unclean samples and semi-solid items. Features include: one calibration, one test, quick response, splash-proof packaging, long-term stability, automatic power-off, and more.

型号 Model 24300 is a rugged hand-held pH meter. The chemical-resistant holster and sturdy engineering make it able to withstand the fall of 6 feet onto the concrete floor. The meter will accurately measure pH, voltage and temperature. The large LCD screen is easy to read. This is excellent for drug testing, manufacturing measurement, laboratory applications and teaching use of instruments.

型号 Model 24301 is a waterproof, hand-held, pH meter with built-in Bluetooth data transmission.

完全 Fully waterproof IP67 standard with a large LCD display and the ability to accurately measure pH, voltage, temperature and redox potential. Includes a set of computer graphics and data logging software. The memory can store up to 999 data points. Can be used with the Model 24302 or Model 24303 probes.

TempDot/WarmMark/ColdMark time temperature / cold temperature / warm temperature label

Ÿ Temperature labels are clearly applied to the pharmaceutical industry. A temperature label is attached to each temperature-sensitive kit, vial, cardboard, or any other package to demonstrate that the temperature of the drug is out of control.

The ŸTime Temperature Label /Warm Temperature Label displays the length of time and intensity of the product that is encountered above the normal temperature range of the drug.

The Ÿ cold temperature label reflects whether the product is exposed to condensed temperature.