Temperature Mapping Study on Cold Room

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1 Int. J. Pharm. Sci. Rev. Res., 44(1), May - June 2017; Article N. 54, Pages: Research Article Temperature Mapping Study n Cld Rm Naveen Kumar V, Gangadharappa H V*, Kiran H.C, Harish Gwda G S Department f Pharmaceutics (Pharmaceutical Quality Assurance), Jagadguru Sri Shivarathhreeswara University, Sri Shivarathreeshwara Nagara, Mysuru, Karnataka, India. *Crrespnding authr s hvgangadharappa@jssuni.edu.in Received: ; Revised: ; Accepted: ABSTRACT The purpse f the study was t carry ut temperature mapping f a cld rm. The study was aimed t determine the temperature distributin and the acceptance criteria thrughut the cld rm. The study was carried ut using Kaye RF Val Prbe temperature/humidity data lggers. A ttal f eighteen data lggers were used, which were kept at specific lcatins in the rm thrughut the study perid. Based n the acceptance criteria f the study prtcl, the temperature was t be maintained between 2 C t 8 C. Cld strage is a relatively simple cld rm that is cmmnly used t stre material between 2 C t 8 C. Such cld rms are nw available cmmercially as walk-in chambers and are used fr the strage f critical pharmaceutical prducts, samples, and raw materials where excursins in temperature cnditins may affect the quality f stred material(s) in terms f their appearance (clr), cnsistency, ptency, and impurity levels. Sme f the parameters studied, External temperature cnditins, Dr pening time during handling f material in and /r ut f the Cld Rm, Pwer breakdwn, Air flw velcity thrugh fans (nt less than 2400 CFM (cubic feet per minute), T much material stred in the rm (thermal lad). Hence it is essential t qualify cld strage chambers under the wrst-case scenaris. Keywrds: Temperature mapping, Cld rm, Data lggers. INTRODUCTION Temperature mapping Temperature mapping study and temperature qualificatin study are carried ut generally in pharmaceutical industry. There are different kind f medicines and vaccines which need t be stred and transprted at certain temperatures. Majrity f these medicines and vaccines are under tw categries viz. thse t be stred between 2 t 8 C and hse t be stred between 15 t 25 C. It is imprtant fr the efficacy f the medicine that the same be stred and transprted at the recmmended temperature limits as abve. If the medicine r vaccine ges abve these temperature limits, the medicinal prperties will be gradually lst and mst imprtantly the prducts will nt shw any indicatin that it has been cmprised. In such case the ultimate distributr and user will be unaware f the efficacy f the medicine. The strage is dne in warehuses, cld rms r refrigeratrs and transprtatin is carried ut in bxes, vans, reefers and cntainers. 1 The temperature mapping is accmplished by using temperature indicating prbes cupled with a data lgger fr data accusatin. Questins may be asked regarding the number f prbes t be utilized and their placement in the cld rm fr temperature mapping in the empty rm and the laded rm. The basic cnsideratin shuld be that the prbes are distributed unifrmly in the rm and shuld cver all the vertical planes. MATERIALS AND METHODS Study parameters The purpse f mapping the cld rm is t establish sufficient data t ensure that the cld rm is capable f: Temperature: Maintaining the desired temperature range thrughut the cld rm under extremes f external temperature. Cld spt and ht spt: Identifying ptential ht spt(s) r cld spt(s) in the chamber. Time: Determining the time required fr cnditins t return t specified parameters (as desired) in case f excursins. Effects: Determining the effects f electrical r refrigeratin surce fluctuatins r pwer failure. Design f the chamber is needed t decide n the number f prbes and their lcatins fr temperature mnitring. While designing the mapping study (prtcl), understanding the design f the cld rm is needed. Design f the cld rm A cld rm r chamber is a rm in the shape f a cubical, made with prefabricated Plyurethane Fam (PUF) insulated panels r f brick and mrtar with insulatin t maintain the desired cnditins f temperature and humidity within. Knwing that the seal between any tw Panels are integral, and that there are n penings, ther than the dr, which may disturb the cnditins f the chamber. 2 Internatinal Jurnal f Pharmaceutical Sciences Review and Research Available nline at Cpyright prtected. Unauthrised republicatin, reprductin, distributin, disseminatin and cpying f this dcument in whle r in part is strictly prhibited. 265

2 Int. J. Pharm. Sci. Rev. Res., 44(1), May - June 2017; Article N. 54, Pages: Materials Kaye data lggers The Kaye RF Val prbe system is a wireless thermal validatin system that recrds temperature and humidity data. The Kaye RF Val prbe system is designed fr accurate, cnvenient, and reliable prcess validatin f envirnmental chambers and strage areas. These applicatins include stability chambers, freezers, refrigeratrs and warehuses. A 2.4-GHz RF mesh netwrk and multiple-redundant data strage supprt cmmunicatins and strage f critical validatin data, while safeguards guarantee data integrity, strage and cmpliance with regulatry requirements. The system cnsists f Kaye RF Val Prbe Lggers, a Kaye RF Val Prbe base statin, and Windws-based sftware fr prgramming and reading the lggers, calibrating lggers, verifying their calibratin, and generating reprts (see Figure 1 belw). Data frm multiple wireless lggers is cmbined in a single file frm which reprts are generated. These reprts are designed fr implementatin f 21 CFR Part 11 requirements fr electrnic recrds. Users can custmize the reprts by defining prcess cycles and specifying cycle-based calculatins. Figure 1: Kaye RF Val prbe data lggers 3 Table 1: Details f lgger used and there lcatins Sl. N. Mdel Sensr Serial Number Lcatin f Sensrs 1. Kaye Val prbe B08439 S1 2. Kaye Val prbe B08461 S2 3. Kaye Val prbe B08512 S3 4. Kaye Val prbe B08615 S4 5. Kaye Val prbe B08616 S5 6. Kaye Val prbe B08627 S6 7. Kaye Val prbe B08628 S7 8. Kaye Val prbe B08631 S8 9. Kaye Val prbe B08659 S9 10. Kaye Val prbe B08668 S Kaye Val prbe B08670 S Kaye Val prbe B08683 S Kaye Val prbe B08758 S Kaye Val prbe B08767 S Kaye Val prbe B08771 S Kaye Val prbe B08776 S Kaye Val prbe B08795 S Kaye Val prbe B08788 S18 Methdlgy Parameters that may affect the cnditin f the cld rm It is desired that the cld rm chamber prvide cntrlled temperature cnditins. There are several parameters that may have an impact n the cnditin f the cld rm. These include: External temperature cnditins Dr pening time during handling f material in and /r ut f the cld rm Pwer breakdwn Internatinal Jurnal f Pharmaceutical Sciences Review and Research Available nline at Cpyright prtected. Unauthrised republicatin, reprductin, distributin, disseminatin and cpying f this dcument in whle r in part is strictly prhibited. 266

3 Int. J. Pharm. Sci. Rev. Res., 44(1), May - June 2017; Article N. 54, Pages: Air flw velcity thrugh fans (nt less than 2400 CFM (cubic feet per minute) T much material stred in the rm (thermal lad) Therefre, during the mapping study the abve listed parameters shuld be subjected as simulated wrst-case cnditins because these parameters may have an impact n the perfrmance f the cld rm. Studies 1. Empty chamber temperature mapping a. Dr pen and recvery study b. Pwer failure and recver study 2. Laded chamber temperature mapping a. Dr pen and recvery study b. Pwer failure and recver study c. Cme up study Empty chamber temperature mapping Dr pen and recvery study T verify the rm was capable f recver t the acceptable limit after the keeping the dr f rm fr 10 min and find ut recvery time. Ensure that the rm was in empty cnditin Ensure the rm was switched ON and in running cnditin. The temperatures f all sensrs were within limit. Rm dr was fr a perid f 10 min. Temperature was lgged in the data lgger fr every 10 secnds, during the dr pening study perid. The dr was clsed after 10 min. The temperature was maintained until all the sensrs at varius lcatins achieve the acceptance range. The temperature data was analysed and find ut the recvery time. The details f the study were recrded in reprt. Pwer failure and recvery study Pwer failure tests were carried ut t check the duratin fr which temperature remains within the limits after a pwer failure. This study was fr infrmatin nly and nt fr qualificatin. This particular cld rm lasted fr 5 hurs befre temperature reached 8 C. Thereafter temperature recvery test was carried ut t understand the duratin taken t attain the desired level f 4 C. This test als was carried fr infrmatin s that custmer will aware f the duratin in cases f emergency. As the cld rm was already laded with medicine, culd nt be carried ut the tests beynd 8 C, hwever varius ther tests were carried ut evaluate the entire cld rm. The whle tests temperature and humidity mapping lasted fr arund 36 hurs. During the recrding f temperature and humidity, all ther nrmal activities were taking place such as lading, unlading, pening f drs etc. and were recrded fr analysis. Temperature mapping study was the majr part f the entire prcess identifying the ht and cld spts f the entire rm. The ht and cld spts ccur fr varius reasns and can be eliminated r reduced by varius means. Ptential reasns fr the same will be identified during the prcess. Laded chamber temperature mapping Dr pen and recvery study T verify the rm was capable f recvery t the acceptable limit after the keeping the dr f rm fr 10 min and find ut recvery time. Ensured that the rm is in laded cnditin Ensured the rm was switched ON and in running cnditin. The temperatures f all sensrs are with in limit. The rm dr was pened fr a perid f 10 min. The temperature in the data lgger was lgged fr every 10 secnds, during the dr pening study perid. The dr was clsed after 10 min. The temperature was mnitred until all the sensrs at varius lcatins achieve the acceptance range. The temperature data was analysed and fund ut the recvery time. The details f the study were recrded in reprt. Pwer failure and recver study Ensured that the instrument is ON cnditin and the temperature display readings are in 2-8 C. The sampling interval kept 01 minute in the data lgger. The pwer supplies were switched ff t the instrument, and Open the Dr f the Cld rm. The details were recrded in the reprt. Temperature mapping was perfrmed till the any ne external sensrs temperature ges beynd 25 C. Recrd the time taken by the sensr t reach 25 C. The drs were clsed and turn ON the pwer supply f the instrument and ensured that all the sensrs temperature reaches its acceptance criteria 2-8 C. The Recvery time were dcumented fr each sensr frm the time f dr clsing. Cme up study The data lggers were switched ON fr recrding at an interval f 10 secnds. The Cld rm was laded with the necessary materials as per the client requirements. D nt verlad the materials. The temperature was set f required range and switch n the instrument. Internatinal Jurnal f Pharmaceutical Sciences Review and Research Available nline at Cpyright prtected. Unauthrised republicatin, reprductin, distributin, disseminatin and cpying f this dcument in whle r in part is strictly prhibited. 267

4 Int. J. Pharm. Sci. Rev. Res., 44(1), May - June 2017; Article N. 54, Pages: The temperature was mnitred fr the required perid till all the sensrs reach acceptance criteria. Once the required temperature is attained, prceed t the next study The details f the study were recrded in reprt. 4 RESULTS AND DISCUSSION Perfrmance qualificatin studies Tw separate studies are required t be perfrmed fr PQ. One study shuld be cmpleted fr the temperature distributin in an empty rm r chamber running cntinually fr 24 h. The secnd wuld be a temperature distributin study in a laded rm r chamber. Lad the bxes with material that simulates a thermal lad, such as starch, lactse, r water in bttles (in case liquid is t be stred in the chamber) recrd the temperature intermittently fr 72 h. each, fr three seasns (i.e., peak Summer, Mnsn (as applicable), and winter) t demnstrate that there is n effect f seasnal variatins n the temperature cntrls in the cld rm. Sampling interval 10 Min (Fr 24 h static cnditin and 48 h.dynamic cnditin) 10 secnds (Fr 10 M pwer failure study, 90 sec dr pening study, 10 minutes dr pening study, hld ver study) Justificatin fr prbe lcatins Table 2: Data lggers lcatins inside cld rm 5 Prbe lcatin shuld be decided lgically, strategically, and scientifically. The fllwing lcatins cver the entire rm. See the (figure 2) Figure 2: schematic representatin f data lggers inside cld rm. Sl.N. Temperature Sensrs Lcatin 1. S1 Left back crner tp 2. S2 Left back crner bttm 3. S3 Left frnt crner tp 4. S4 Left frnt crner bttm 5. S5 Right frnt crner tp 6. S6 Right frnt crner bttm 7. S7 Right back crner tp 8. S8 Right back crner bttm 9. S9 Middle f the left wall Justificatin Selected fr temperature mapping t study the temperature distributin at left crners f the rack and lcatin is away frm air currents. Selected fr temperature mapping t study the temperature distributin at right crners f the rack and lcatin is away frm air currents. selected fr temperature mapping as lcatin is Near Crner f the rm, away frm air currents, near t the material strage area 10. S10 Middle f the back wall Selected fr temperature mapping t study the temperature distributin 11. S11 Middle f the right wall at the middle f the rack which is Material strage area 12. S12 Near the dr S13 Near the dr S14 Middle f the right rack 15. S15 Near cntrlling prbe 16. S16 Middle f the left rack 17. S17 Centre f the rm 18. S18 Kept utside the cld rm fr ambient temperature Man& material mment area. Selected fr temperature mapping t study the temperature distributin at the middle f the rack which is Material strage area Cmparisn f temperature prfile f inbuilt sensr prbe with external sensr Selected fr temperature mapping t study the temperature distributin at the middle f the rack which is Material strage area Selected fr temperature mapping t study the temperature distributin at the middle f the rm which is Material strage area Rm temperature. Internatinal Jurnal f Pharmaceutical Sciences Review and Research Available nline at Cpyright prtected. Unauthrised republicatin, reprductin, distributin, disseminatin and cpying f this dcument in whle r in part is strictly prhibited. 268

5 Int. J. Pharm. Sci. Rev. Res., 44(1), May - June 2017; Article N. 54, Pages: Hurs static study Graph 1: A graph f temperature distributin f the cld rm 24 h. Table 3: Study summary24 Hurs static cnditin. Senr/lgger Sl. Min Max Avg Max-Min B08439 (C) B08461 (C) B08512 (C) B08615 (C) B08616 (C) B08627 (C) B08628 (C) B08631 (C) B08659 (C) B08668 (C) B08670 (C) B08683 (C) B08758 (C) B08767 (C) B08771 (C) B08776 (C) B08795 (C) B08788 (C) Static Study Static study was cnducted fr 24 Hrs. Frm Table n 3 and graph n 1, shws the study was bserved and recrded that minimum and minimum average temperature at lcatin S5 was fund 2.44 C and 4.15 C respectively. Similarly maximum and maximum average temperature at lcatin S2 was fund 5.74 C and 5.35 C respectively. Dynamic Study Dynamic study was cnducted fr 48 Hrs. Frm Table n 4 and graph n 2, shws the study was bserved and recrded that minimum and minimum average temperature at lcatin S5 was fund 2.43 C and 4.15 C respectively. Similarly maximum and maximum average temperature at lcatin S2 was fund 5.71 C and 5.32 C respectively. Internatinal Jurnal f Pharmaceutical Sciences Review and Research Available nline at Cpyright prtected. Unauthrised republicatin, reprductin, distributin, disseminatin and cpying f this dcument in whle r in part is strictly prhibited. 269

6 Int. J. Pharm. Sci. Rev. Res., 44(1), May - June 2017; Article N. 54, Pages: Hurs Dynamic study Graph 2: A graph f temperature distributin f the cld rm 48 h. Table 4: Study summary 48 hurs dynamic cnditin. Senr/lgger Sl. Min Max Avg Max-Min B08439 (C) B08461 (C) B08512 (C) B08615 (C) B08616 (C) B08627 (C) B08628 (C) B08631 (C) B08659 (C) B08668 (C) B08670 (C) B08683 (C) B08758 (C) B08767 (C) B08771 (C) B08776 (C) B08795 (C) B08788 (C) Internatinal Jurnal f Pharmaceutical Sciences Review and Research Available nline at Cpyright prtected. Unauthrised republicatin, reprductin, distributin, disseminatin and cpying f this dcument in whle r in part is strictly prhibited. 270

7 Int. J. Pharm. Sci. Rev. Res., 44(1), May - June 2017; Article N. 54, Pages: Wrst case study 10 minutes Dr pen study Graph 3: A graph f temperature distributin f the 10 min dr pening study. Table 5: Study summary 10 min dr pen study. Senr/lgger Sl. Min Max Avg Max-Min B08439 (C) B08461 (C) B08512 (C) B08615 (C) B08616 (C) B08627 (C) B08628 (C) B08631 (C) B08659 (C) B08668 (C) B08670 (C) B08683 (C) B08758 (C) B08767 (C) B08771 (C) B08776 (C) B08795 (C) B08788 (C) Dr Opening Study fr 10 Min Dr pening study was cnducted fr 10 min. Frm Table n 5and graph n 3, shws the study was bserved and recded that minimum and minimum Average temperature at lcatin S7 was fund 4.32 C and S C respectively. Similarly maximum and maximum average temperature at lcatins11 was fund C and S Crespectively.Recvery time was bserved 06 min 30 Sec. Internatinal Jurnal f Pharmaceutical Sciences Review and Research Available nline at Cpyright prtected. Unauthrised republicatin, reprductin, distributin, disseminatin and cpying f this dcument in whle r in part is strictly prhibited. 271

8 Int. J. Pharm. Sci. Rev. Res., 44(1), May - June 2017; Article N. 54, Pages: secnds Dr pen study Graph 4: A graph f temperature distributin f the 90 secnds dr pening study. Table 6: Study summary 90 secnds dr pening study. Senr/lgger Sl. Min Max Avg Max-Min B08439 (C) B08461 (C) B08512 (C) B08615 (C) B08616 (C) B08627 (C) B08628 (C) B08631 (C) B08659 (C) B08668 (C) B08670 (C) B08683 (C) B08758 (C) B08767 (C) B08771 (C) B08776 (C) B08795 (C) B08788 (C) Dr Opening Study fr 90 sec Dr pening study was cnducted fr 90 sec. Frm Table n 6and graph n 4, shws the study was bserved and recrded that minimum and minimum Average temperature at lcatin S7 was fund 4.21 C and S C respectively. Similarly maximum and maximum average temperature at lcatin S11 was fund C and 7.46 Crespectively. Recvery Time was bserved 01 Min. Internatinal Jurnal f Pharmaceutical Sciences Review and Research Available nline at Cpyright prtected. Unauthrised republicatin, reprductin, distributin, disseminatin and cpying f this dcument in whle r in part is strictly prhibited. 272

9 Int. J. Pharm. Sci. Rev. Res., 44(1), May - June 2017; Article N. 54, Pages: Hld ver study Graph 5: A graph f temperature distributin f the hld ver study. Table 7: Study summary Hld ver study. Senr/lgger Sl Min Max Avg Max-Min B08439 (C) B08461 (C) B08512 (C) B08615 (C) B08616 (C) B08627 (C) B08628 (C) B08631 (C) B08659 (C) B08668 (C) B08670 (C) B08683 (C) B08758 (C) B08767 (C) B08771 (C) B08776 (C) B08795 (C) B08788 (C) Hld ver study Hld ver study was cnducted. Frm Table n7 and graph n 5, shws the study was bserved and recrded that minimum and minimum Average temperature at lcatin S10 was fund 3.58 C and S C respectively. Similarly maximum and maximum average temperature at lcatin S5 was fund 8.01 C and 6.72 Crespectively. The hld ver time was bserved t be 53 min and 50 sec. S C respectively. Temperature excursins were nt bserved beynd acceptance criteria during the study. 10 minutes pwer failure study Pwer Failure Study Pwer failure study was cnducted fr 10min. Frm Table n8and graph n 6, shws the study was bserved and recrded that minimum and minimum Average temperature at lcatin S7 was fund 3.90 C and S C respectively. Similarly maximum and maximum average temperature at lcatin S3 was fund 5.50 C and Graph 6: A graph f temperature distributin f the 10 min pwer failure study. Internatinal Jurnal f Pharmaceutical Sciences Review and Research Available nline at Cpyright prtected. Unauthrised republicatin, reprductin, distributin, disseminatin and cpying f this dcument in whle r in part is strictly prhibited. 273

10 Int. J. Pharm. Sci. Rev. Res., 44(1), May - June 2017; Article N. 54, Pages: Table 8: Study summary 10 min pwer failure study Senr/lgger Sl Min Max Avg Max-Min B08439 (C) B08461 (C) B08512 (C) B08615 (C) B08616 (C) B08627 (C) B08628 (C) B08631 (C) B08659 (C) B08668 (C) B08670 (C) B08683 (C) B08758 (C) B08767 (C) B08771 (C) B08776 (C) B08795 (C) B08788 (C) CONCLUSION Temperature and relative humidity mapping are the essential studies t be carried ut in pharmaceutical industries fr the maintenance f drug stability and safety during strage and transprt until when the prduct reaches the custmer. This study was carried ut t map temperature and relative humidity f a cld rm fr a perid f 72 h. The results were fund t be gd and within the acceptance criteria. CFR: Cde f Federal Regulatins GDP: Gd Distributin Practice PQ: Perfrmance Qualificatin PUF: Plyurethane Fam SOP: Standard Operating Prcedure USP: United States Pharmacpeia REFERENCES 1. Fd and Drug Administratin, 21CFR and (Strage and Distributin). 2. The United States Pharmacpeia, Chapter 1079: Gd Strage and Shipping Practices envirnmentalmnitring/envirnmental-mnitring/kayerf-valprbe-2-lggers. 4. Temperature validatin prtcl wrst case study prtcl fr walk-in chamber (2-8 C) BF/QCQ8/STY/P/ Medicines and Healthcare Prducts Regulatry Agency, Rules and Guidance fr Pharmaceutical Manufacturers and Distributrs 2007, Sectin IV Guidance n Whlesale Distributin Practice pg 358. Surce f Supprt: Nil, Cnflict f Interest: Nne. Internatinal Jurnal f Pharmaceutical Sciences Review and Research Available nline at Cpyright prtected. Unauthrised republicatin, reprductin, distributin, disseminatin and cpying f this dcument in whle r in part is strictly prhibited. 274