稳压系统

涅磐心殇

GMP认证中有没有对液相、气相的稳压系统有要求啊？我们的液相和气相都没有配UPS稳压器，需不需要陪呢？需要的话有什么好的推荐一下

大草原制药人

如果突然断电那你们的OOS怎么做。

APHI

需要配置稳压电源的，不光这样接地也是有特殊要求。

wgt-王

GMP认证对稳压系统没要求！

Whats

需要陪

小兵

陪吧  

yaozhi

1、UPS是不间断电源，就是异常停电了也能保证不断电一段时间。（一般都会配，以防万一）
2、稳压电源是保证上游市电电网电压发生波动时，接在稳压电源后面的用电仪器电压稳定的设备；（根据电网电压质量情况来定）
3、像液相、质谱等精密仪器说明书中要求“零地电压小于0.5V”，高了会烧主板，所有有时还会配备隔离变压器来保证零地电压符合要求。（检测后确定）
一个稳定性无法得到保证的检测仪器应该不符合GMP要求，所以请按实际情况选择配吧！

快乐的小鱼

象这样的精密仪器一般都是需要配稳压电源的：一是防止突发情况断电后保存数据；二是在电压发生急剧变化时保护设备

beiwei5du

Power: The Unregulated Utility in Pharmaceutical Environment
Sat, 05/01/2004 - 12:00am
by Nissan Cohen
Utility power in a pharmaceutical environment is unregulated by the FDA. Pharmaceutical/Biotechnology companies are dependent on the quality of the power provided by the local utility. There are many issues regarding unconditioned power provided by a utility versus conditioned power provided by an Uninterruptible Power System (UPS). The increasing complexity of computers, computer systems, microprocessor-controlled processes, and the interaction of IT systems and computerized process systems has created a power requirement structure for pharmaceutical/biotechnology processing that is unparalleled. The power provided by the utilities can vary greatly in voltage, frequency, and electrical noise. This paper will delineate the most common problems with utility power, how to rectify and minimize the exposure to power inconsistencies, and protect and maintain mission-critical processes and environments.

Historical Background

Power has never been regulated in the pharmaceutical industry as it is not considered an active ingredient nor component in pharmaceutical processing or manufacturing. However, all pharmaceutical and biotechnology facilities use power. Power is supplied by the utility. In cases of a power outage, power is generated on-site by using auxiliary generator systems or supplied by emergency batteries. The lag time between the loss of power and the supply from the generator or batteries, is usually 10 - 30 seconds. This is a short duration in physical time but could be catastrophic in process loss.

Utility power voltages and supply can deviate from -7.5% to +7.5% from an absolute voltage value by law. Thus, a 208-phase voltage can range from 192 - 223 volts, as supplied by the power utility. This wide deviation from 208 volts is only one possible problem. Power surges, sags, electrical noise, harmonics, load, and other interferences can damage sensitive electrical components and accessories.

Microprocessor-based devices in the pharmaceutical process including controllers, programmable logic controllers (PLCs), PC controllers, and servers are susceptible to power interruptions and fluctuations.

This can result in violation of process parameters, loss of real-time data, loss of process control, loss of archiving data, loss of batch, loss of revenue, etc.

Power Problems and Their Effects on Electronic Circuitry and Devices

Power failure, by definition, is a total loss of utility power. Utility power losses are caused by numerous events including lightning strikes, downed power lines, transformer malfunctions, over demands on the grid, accidents, weather anomalies, and natural disasters. In most systems, some or all of the following situations may occur: file corruption; hardware damage; data loss; data corruption; firmware damage or loss; or malfunction of the computer.

Power Sag: Power sag is a short-term, low voltage supply, from the utility. The duration of a power sag can be extremely short or may last for a few seconds. A power sag can be triggered by various load and utility switching mechanisms. When a large load is started, the grid will yield to the load while stressing the existing supply and load on the grid. Utility equipment failure, utility switching, lightning, large load start-up, and demand that is greater than the power service can handle can all be contributing factors to power sags. Power sags can cause crashes to equipment and hardware damage. Typically, the hardware damage may entail memory loss, data errors, flickering lights, equipment shut-off or malfunction with automatic shut-off.

Power Surge: This is the opposite of a power sag. In this case, the short-term high voltage can be 110% above the nominal supply voltage. Power surges can be caused by lightning strikes sending line voltages above 6,000 volts. Power surges, also known as “power spikes,” invariably result in both data loss and hardware damage. The resulting damage could entail problems similar to power sag.

Undervoltage: Undervoltage, also known as “brownout”, is a condition that may be intentionally induced by the utility. The definition of undervoltage is when line voltage is reduced for an extended period of time—from a few minutes to as long as a few days. The utility may enact a “brownout” during peak demand periods to conserve power. Supply due to heavy loads exceeding the capacity can necessitate an under voltage condition. The effect of the “brownout” can predicate premature hardware failure, data loss and corruption.

Overvoltage: Overvoltage is the opposite state from undervoltage or increased voltage for a duration of time. Overvoltage is a fairly infrequent occurrence but occurs in instances of rapid reduction in power loads, shut-off of heavy equipment, or by utility switching. Overvoltage can incur extensive hardware damage including burned-out circuit boards, component stress or loss, memory loss, data loss and data errors.

Electrical Line Noise: Electrical line noise is a high frequency waveform caused by radio frequency interference (RFI) or electromagnetic interference (EMI). These common interferences in a power supply can be generated by local or remote influences. Equipment such as transmitters, welding devices, SCR driven printers, lightning, and electrical equipment, etc. can generate RFI and EMI conditions. Varying degrees of damage can occur from simple keyboard lock-ups to program failures, data crashes and data corruption.

Switching Transients: By definition, this is an instantaneous undervoltage. Normal duration of this anomaly is less than a “voltage spike,” typically in the range of nanoseconds. Damage may be incurred in both hardware and software resulting in burned circuitry, component stress or failure, memory and data losses.

Harmonic Distortion: Harmonic distortion is the distortion of the normal line waveform. Harmonic distortion is, generally, transmitted by nonlinear loads. Harmonics are a definitive presence in power. Their distortions can be caused by mundane and ubiquitous equipment found in any pharmaceutical plant. Switch mode power supplies, variable speed motors and drives, copiers, fax machines, variable speed pumps are examples of non-linear loads. Harmonic distortions can cause communication errors, overheating, and hardware damage. Common maladies and failures are CPU clock errors, overheating, and premature failure of electrical components.



The Uninterruptible Power Supply

All of the previous described conditions are inherent in an unconditioned or raw power supply. A UPS system is a device for the supply of conditioned power. Conditioned power by definition is the use of an inverter to continuously supply 100% new, clean and regulated AC power. The UPS isolates the downstream equipment from the power problems described above. We see in Figure 1, that the utility voltage is sporadic, ranging from 212 to 217 volts. The actual supply should be at 208 volts. The UPS output voltage is between 207 and 207.81 and a total spread of 0.8 volts. The UPS voltage is consistent and conditioned. The utility voltage is dynamic and unpredictable. As stated before, the power utility can supply voltage from 192 - 223 and still adhere to their specifications. This overvoltage/undervoltage situation can have adverse effects on computers, PLCs, controllers, and data storage devices.

All UPS systems today use battery back-up systems to supply power when the utility power fails. Many pharmaceutical facilities also employ generators. Generator activation due to a utility outage is typically a 10 - 30 second time delay before power is restored. This means, without a UPS system, all of the equipment will be either shutdown or off-line for the duration, from the instant of the power outage until the release of power from the generator. This short duration of power loss can have catastrophic consequences in the pharmaceutical processing areas, laboratory testing facilities, data management, archiving, and acquisition devices.

In a previous article,1 downtime calculations were displayed showing the loss of business revenue and the consequent liabilities. The value of continuous uptime cannot be underestimated, as it affects and benefits throughput, product quality, quality of manufacturing and formulation, quality assurance, quality of data acquisition, archival and retrieval functions, and the quality of internal business delivery.

Uninterruptible pharmaceutical processing, manufacturing, and business operations can only be attained with uninterruptible power. UPSs supply and maintain continuous conditioned power removing the ills of the utility’s raw power.



Mission-Critical Power Installation for a Pharmaceutical Facility

The power usage in a pharmaceutical facility is divided into two unique paths—mission-critical power and non-critical power. Mission-critical power is supplied to uninterruptible operations, processes, and systems. Many pharmaceutical production facilities have 24/7 (24 hours a day/ seven days a week) operations. The biotechnology sector is a prime example of uninterruptible and mission-critical operations. Fermentation, typically of three weeks duration, needs process parameters to be tightly controlled and monitored; any deviation from the proper parameter readings will significantly or permanently impair the product.

Figure 2 shows an electrical one-line, delineating the power paths in mission-critical and non-critical operations. The red lines denote mission-critical power and the black lines non-critical power. The power utility feed is the first-step in the power train. The utility feed connects to a high voltage switchboard. This switchboard monitors the power usage and distributes to the downstream power train. An automatic transfer switch (ATS) is installed to direct the power either from the utility feed source or from the generator. When a power outage occurs, the ATS changes position to allow the generator to feed the power train. The UPS is installed after the ATS. The UPS transmits conditioned power to either distribution boards or to power distribution units (PDUs). These distribution panels transmit the power to individual circuits and to the downstream equipment, devices, process equipment, computers, etc.

As described previously, in case of a power loss or outage, the generator is activated to provide interim power until the utility power is reestablished. The generator power runs to the ATS. The ATS sends the power to the UPS and the rest of the power train. By installing a UPS, two major problems are averted. First, the power supplied to process equipment and computers will always be conditioned power. Second, the power supply time lag due to the start of the generator is eliminated. Generators do not provide conditioned power and should not be used in lieu of an UPS. Generators and UPSs are complimentary components in the mission-critical power train.

Figures 3, 4, and 5 describe the UPS output voltage supply during a power outage. The input voltage and output voltage of the UPS are identified with the black and blue traces. The time increment on Figure 3 is 1 hour and 54 minutes. Figure 4 elucidates the failure of the input voltage from the utility at 5:53 PM on 5/28/03. The yellow line shows the exact instance of the power failure with input voltage drop to 0. The UPS output voltage remains unaffected at 207 volts. Figure 5 depicts the reestablished supply of power at 6:53 PM and the jump of voltage from 0 to 212. During the outage, the UPS provided continuous power at 207 volts with no interruption of service. All computer, process, and telecommunication functions remained on-line and in-service with no data loss or corruption. Most importantly, no loss of business was incurred.

Summary

Utility power supply can vary greatly. Overvoltage, undervoltage, surges, sags, harmonics, electrical line noise, transients, lightning etc. are potential power problems that can induce damage to computers, controllers, PLCs, microprocessors, and circuitry. UPSs will negate the utility power problems and supply continuous on-line conditioned power to all downstream equipment. UPSs should be installed on all mission-critical circuits servicing mission-critical equipment and processes. Generators and UPSs should be installed as complementary technology.



Reference

1 N. Cohen. “Monitoring Mission-Critical 24/7 Data Centers in a Pharmaceutical Facility”, Pharmaceutical Engineering (Jan/Feb, 2002).

Additional Readings

N. Cohen. “Monitoring Mission-Critical 24/7 IT Data Centers in a Pharmaceutical Facility,” Pharmaceutical Engineering, Vol.22, No.1 (January/February, 2002).

J. F. Maida. “Economic and Reliable Power Sources for Pharmaceutical Facilities,” Pharmaceutical Engineering, Vol. 21 No.2 (March/April 2001).

“What’s the Harm in Harmonics? A concise report on the effects of harmonic distortion on computers,” Powerware Corporation DataTrax Systems