Validation of a Laboratory I ncubator U sing Wireless and ...

1 V alidation of a L aboratory I ncubator U sing Wireless and C abled Datalogger P art I I . By Laura Valdes-Mora Elite MicroSource Corporation and Pamela Hardt-English PhF Specialists, Inc.. T. he following article describes ber 31487. This is a gravity convec- the various steps regarding T his Validation tion unit model number 6M with an the Installation Qualification was designed operating temperature range of 25 C. (IQ), Operational Qualification (OQ) to 70 C. The incubator has the fol- and Performance Qualification (PQ) and per for med lowing electrical characteristics: that were executed to complete the fr om the Validation of a pharmaceutical micro- Volts- 120. biology Laboratory incubator. This viewpoint of a Hertz- 50/60. Validation was designed and per- micr obiologist Watts- 300. formed from the viewpoint of a microbiologist with assistance from with assistance The overall dimensions of the Validation experts. The protocol used fr om Validation unit are 42 X 21 X 39 with cham- for this Validation was previously ber dimensions 36 X 18 X 27.

2 The published in the Journal of Valida- exper ts. incubator contains a dual hydraulic tion thermostat, a mercury-in-glass ther- mometer, two shelves, two heaters, double inner Descr iption of the I ncubator Unit doors, and double outer doors. The incubator is a conventional unit where fresh Installation Qualification (IQ). air enters though an air intake at the bottom. The air During the IQ, personnel documented all items list- is heated at a plenum below the chamber and flows ed in the Incubator IQ Form. Refer to Appendix A of into the chamber in a uniform flow pattern. Exhaust Validation protocol, previously published in the air is vented through a port at the top of the incubator. Journal of Validation Technol A second person The unit is a Precision Thelco Incubator catalog num- reviewed and approved all verifications. Laura Valdes-Mora & Pamela Hardt-English Purpose Notes: The ground wire is connected. Non-load IQ was conducted to demonstrate that the piece cycle Amps = of equipment was inspected, and contains all the required parts for its proper functioning.

3 The pres- An Uninterrupted Power Supply (UPS) is not ence/absence of external equipment aides (recorder used on this incubator. charts, etc.) was also documented. This unit is not hooked to a back-up generator. List of Standard Operating Procedures (SOPs). E quipment and Materials associated with this incubator; the SOPs were list- Incubator ed by number, title, and revision number. They Appendix A are not included in the article as SOPs, and are confidential documents of the company where we IQ Observations conducted this Validation . SOPs were reviewed Incubator Description The unit is a Precision and were found to be appropriate. Thelco Incubator, catalog number 31487. The The incubator does not have a temperature display. temperature range it is designed for is from There is an external temperature recorder in use room temperature to 70 C. The unit uses 120 for this unit, which is a Dickson Temptrace Re- volts and amps. This incubator had not been corder Chart. The recorder chart is identified as previously validated, and was 29 years and number one and contains a replaceable seven-day seven months old at the time this Validation was chart (graph).

4 Conducted. Acceptance criteria were met. Incubator Model Number is 6M. Incubator Serial Number 22-AG-8. Operational Qualification: (OQ). Incubator was purchased on July 14, 1971 from In this section the performance of the equipment Precision Scientific. and its operational procedure was verified. The OQ. Vendor Manual is available. of an incubator consists of an empty chamber tem- Location of Vendor Manual The manual can be perature mapping. found in the file cabinet of the microbiology lab- oratory. Purpose Drawings for the incubator are available and The OQ was performed to confirm that the empty located in the vendor manual. chamber works within the specified limits of tem- Utilities required Electricity is required for this perature (32 to 37 C) throughout the chamber. unit. The power source was found to be present and functional. A member of the maintenance E quipment and Materials department measured the Volts and the amper- Precision Thelco Incubator (32-37 C). age reading of the circuit of the electrical outlet Real Time Datalogger - Ellab Model TM9616.

5 Where the incubator is plugged in. The data were Real Time Datalogger recorded as found. Serial Number 00270110141. Thermocouples Type T (Cu/Con). Utility Data Wireless Data Loggers . Circuit Rating: Ellab Model TSM9803. 130 Volts 1 Phase 60 Hertz 20 Amps Serial Number 2056. Equipment Rating: Temperature Sensor Serial Number 125 Volts 1 Phase 60 Hertz Amps LC 1 20022 6422. Field Measurement: LC 2 20753 5757. Volts 1 Phase 60 Hertz Amps LC 3 20770 5747. LC 4 20764 5770. Cord and Plug NEMA Designation: 5-15 P LC 5 20804 5766. Wall receptacle NEMA Designation: 5-15R LC 6 20717 5309. Laura Valdes-Mora & Pamela Hardt-English LC 7 20713 5219 In the diagrams seen for the top and lower shelf, LC 8 20703 4521 each number corresponds to the thermocouple and LC 9 11542 5679 the logger placed at the location. The two devices LC 10 11537 4553 were side-by-side for each one of the locations indi- Windows-based PC or laptop computer to oper- cated. The box in the lower shelf with an R in the ate data loggers center indicates the location of the chart recorder, as External Temperature Device shown in Figure 2.

6 Timer Figure 2. E quipment Picture R elative P os ition of the See Figure 1. T hermoc ouples and Figure 1 Wireles s S ens ors Top S helf E mpty C hamber S et-Up 1 2. 3. 4 5. Front L ower S helf 6 R 7. 8. 9 10. Front E mpty Tests for Temperature Setting Acceptance Criterion The incubator was set to 35-37 Cor 36 + 1 C. All sites measured are within 32-37 C. While TCs were being placed, the incubator was opened for 20 minutes. It took 30 minutes after clos- OQ Observations ing the doors of the incubator for the unit to reach Calibration 35 C. Note that the chart recorder was reading C. The calibration of thermocouples was performed An additional reading of the recorder indicated the using a Kaye LTR-140 serial number 5C339H, owned temperature to be C. by the pharmaceutical company where we conducted Test of temperature setting number one (lowest this Validation . A total of 12 Thermocouples (TCs) temperature setting on this incubator). In order to were tested, and 10 of those were used for the tem- expedite the decrease in temperature, we opened the perature profiles.

7 Calibrations were satisfactorily con- door of the incubator for a few minutes. The temper- ducted according to the SOPs. The two extra calibrat- ature decreased to a range between 25-29 ed thermocouples were kept in reserve in case of a closing the door and allowing TC s to stabilize, the failure of one of the others. lowest temperature recorded was 29 C, as shown in Fi gure 3. Location of Thermocouples and Loggers- Dia- Test of Temperature Setting #9 (highest safe grams: The purpose of the diagram is to show the temperature setting on this incubator). Safety light relative position of the thermocouples and Wireless came on at 66 C. Chart recorder read C, while sensors. The figure is not to scale. the TC next to the recorder chart read Cas Laura Valdes-Mora & Pamela Hardt-English Figure 3 Figure 4. R es ults of L o w R es ults of High Temperature S etting Temperature S etting 00:37 00:42. S etting TC 1 Top Shelf Back Left TC 8 Bottom Shelf Center TC 2 Top Shelf Back Right TC 9 Bottom Shelf Left Front TC 3 Top Shelf Center TC 10 Bottom Shelf Front Right TC 4 Top Shelf Front Left TC 13 Description TC 5 Top Shelf Front Right TC 14 Description TC 6 Bottom Shelf Back Left TC 15 Description TC 7 Bottom Shelf Back Right TC 16 Description shown in Fi gure 4.

8 It appears that the chart recorder responds more slowly than the thermocouples to 01:08 01:13 01:18 01:23. temperature changes. S etting Due to the fact that the safety light came on during TC 1 Top Shelf Back Left TC 8 Bottom Shelf Center this test, it was decided to record current tempera- TC 2 Top Shelf Back Right TC 9 Bottom Shelf Left Front TC 3 Top Shelf Center TC 10 Bottom Shelf Front Right tures, and set the knob back to its regular setting of TC 4 Top Shelf Front Left TC 13 Description number five. The incubator manual was reviewed, TC 5 Top Shelf Front Right TC 14 Description TC 6 Bottom Shelf Back Left TC 15 Description and it was found that the safety light is related to a TC 7 Bottom Shelf Back Right TC 16 Description safety thermostat, which operates alternatively to the control thermostat. be 26 hours, 44 minutes, and 39 seconds. After increasing the temperature as per step num- At 03:52:40 PM, all TCs were within temperature ber three, it took the incubator 75 minutes to come range.

9 There were still some hot pockets left from down to the set temperature range of 35-37 C. the previous study. It took the chamber an addition- Once all thermocouples were within the tempera- al 42 minutes to stabilize all locations. ture range established by the protocol (32-37 C), The data obtained show that all thermocouples with the understanding that temperature readings were within the specified temperature range for 24. can range from up to C (per rounding hours as shown in Figure 5. rules), the 24-hour mapping study was started. Wi reless Datalogger, Tracksense: The study start- 24-Hour Temperature Mapping ed at 08:43:00. All Wireless loggers (LCs) were at the The empty chamber test was conducted for over target temperature range at 10:07:00 as shown in 24 hours. Temperature readings were recorded every Fi gure 6. It took the sensors 1 hour and 24 minutes to two minutes. From the time the run was started all be stabilized. This is almost double the amount of (02:10:40 PM) to its end, the time was determined to time it took the TC s to get into temperature range.

10 Laura Valdes-Mora & Pamela Hardt-English Figure 5 Figure 6. R es ults of 24-Hour E mpty R es ults of 24-Hour E mpty C hamber Mapping C hamber Mapping T hermoc ouples Wireles s Trac ks ens e 02:40 07:25 12:10 16:55 21:40 08:43-1 13:28-1 18:13-1 22:58-1 03:43-2. S etting S etting TC 1 Top Shelf Back Left TC 8 Bottom Shelf Center LC 1 Top Shelf Back Left LC 6 Bottom Shelf Back Left TC 2 Top Shelf Back Right TC 9 Bottom Shelf Left Front LC 2 Top Shelf Back Right LC 7 Bottom Shelf Back Right TC 3 Top Shelf Center TC 10 Bottom Shelf Front Right LC 3 Top Shelf Center LC 8 Bottom Shelf Center TC 4 Top Shelf Front Left TC 13 Description LC 4 Top Shelf Front Left LC 9 Bottom Shelf Left Front TC 5 Top Shelf Front Right TC 14 Description LC 5 Top Shelf Front Right LC 10 Bottom Shelf Front Right TC 6 Bottom Shelf Back Left TC 15 Description TC 7 Bottom Shelf Back Right TC 16 Description temperature setting test was completed immediately In order for this to be a 24-hour run, the readings prior to the empty chamber mapping.